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Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer (CheckMate 7FL)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
nivolumab
paclitaxel (PTX)
nivolumab placebo
anthracycline
cyclophosphamide
Endocrine Therapy
Surgery
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Nivolumab, Breast Cancer, Cancer, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor 2 Negative (HER2-), Neoadjuvant, Adjuvant, Primary Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.
  • Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines.
  • Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.
  • Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%
  • Must agree to provide primary breast tumor tissue at baseline and at surgery
  • Must be deemed eligible for surgery
  • Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial
  • Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1

Exclusion Criteria:

  • Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment
  • Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association
  • History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time
  • Definitive clinical or radiologic evidence of metastatic disease
  • Multicentric BC (the presence of > 1 tumor in different quadrants of the breast)
  • Bilateral invasive BC

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0136
  • Local Institution - 0052
  • Local Institution - 0051
  • Local Institution - 0182
  • Local Institution - 0150
  • Local Institution - 0097
  • Local Institution - 0149
  • Local Institution - 0120
  • Local Institution - 0054
  • Local Institution - 0107
  • Local Institution - 0056
  • Local Institution - 0221
  • Local Institution - 0227
  • Local Institution - 0222
  • Local Institution - 0146
  • HCA Midwest Division
  • Local Institution - 0109
  • Local Institution - 0050
  • Local Institution - 0180
  • Local Institution - 0181
  • Local Institution - 0041
  • Local Institution - 0283
  • Duke Cancer Institute
  • Local Institution - 0053
  • Local Institution - 0218
  • Local Institution - 0121
  • Local Institution - 0224
  • Local Institution - 0122
  • Virginia Cancer Institute
  • Local Institution - 0274
  • Local Institution - 0012
  • Local Institution - 0015
  • Local Institution - 0294
  • Local Institution - 0303
  • Local Institution - 0011
  • Local Institution - 0008
  • Local Institution - 0013
  • Local Institution - 0014
  • Local Institution - 0020
  • Local Institution - 0021
  • Local Institution
  • Local Institution
  • Local Institution - 0071
  • Local Institution - 0069
  • Local Institution - 0072
  • Local Institution - 0067
  • Local Institution - 0066
  • Local Institution - 0142
  • Local Institution - 0070
  • Local Institution - 0068
  • Local Institution - 0045
  • Local Institution - 0042
  • Local Institution - 0048
  • Local Institution - 0046
  • Local Institution - 0047
  • Local Institution - 0187
  • Local Institution - 0030
  • Local Institution - 0037
  • Local Institution - 0032
  • Local Institution - 0031
  • Local Institution - 0130
  • Local Institution - 0225
  • Local Institution - 0287
  • Local Institution - 0133
  • Local Institution - 0132
  • Local Institution - 0288
  • Local Institution - 0131
  • Local Institution - 0135
  • Local Institution - 0273
  • Local Institution - 0134
  • Local Institution - 0272
  • Local Institution - 0128
  • Local Institution - 0129
  • Local Institution - 0144
  • Local Institution - 0104
  • Local Institution - 0194
  • Local Institution - 0095
  • Local Institution - 0058
  • Local Institution - 0197
  • Local Institution - 0016
  • Local Institution - 0019
  • Local Institution - 0318
  • Local Institution - 0018
  • Local Institution - 0326
  • Local Institution - 0235
  • Local Institution - 0239
  • Local Institution
  • Local Institution - 0215
  • Local Institution - 0319
  • Local Institution - 0232
  • Local Institution - 0267
  • Local Institution - 0241
  • Local Institution
  • Local Institution - 0312
  • Local Institution - 0240
  • Local Institution - 0250
  • Local Institution - 0248
  • Local Institution
  • Local Institution - 0255
  • Local Institution - 0247
  • Local Institution - 0252
  • Local Institution - 0263
  • Local Institution - 0245
  • Local Institution - 0256
  • Local Institution - 0214
  • Local Institution - 0127
  • Local Institution - 0244
  • Local Institution - 0254
  • Local Institution - 0311
  • Local Institution - 0238
  • Local Institution - 0231
  • Local Institution - 0237
  • Local Institution - 0261
  • Local Institution - 0203
  • Local Institution - 0113
  • Local Institution - 0094
  • Local Institution - 0098
  • Local Institution - 0093
  • Local Institution - 0271
  • Local Institution - 0202
  • Local Institution - 0100
  • Local Institution - 0103
  • Local Institution - 0101
  • Local Institution - 0099
  • Local Institution - 0167
  • Local Institution - 0165
  • Local Institution - 0164
  • Local Institution - 0166
  • Local Institution - 0001
  • Local Institution - 0160
  • Local Institution - 0216
  • Local Institution - 0004
  • Local Institution - 0024
  • Local Institution - 0162
  • Local Institution - 0153
  • Local Institution - 0152
  • Local Institution - 0161
  • Local Institution - 0195
  • Local Institution - 0002
  • Local Institution - 0258
  • Local Institution - 0228
  • Local Institution - 0003
  • Local Institution - 0084
  • Local Institution - 0079
  • Local Institution - 0083
  • Local Institution - 0112
  • Local Institution - 0081
  • Local Institution - 0158
  • Local Institution - 0223
  • Local Institution - 0087
  • Local Institution - 0089
  • Local Institution - 0080
  • Local Institution - 0196
  • Local Institution - 0111
  • Local Institution - 0156
  • Local Institution - 0157
  • Local Institution - 0105
  • Local Institution - 0115
  • Local Institution - 0034
  • Local Institution - 0036
  • Local Institution - 0035
  • Local Institution - 0191
  • Local Institution - 0207
  • Azienda Ospedaliero Universitaria Federico II di Napoli
  • Istituto Nazionale Tumori Fondazione Pascale
  • Istituto Oncologico Veneto IOV
  • Fondazione Irccs - Policlinico San Matteo
  • Policlinico Universitario Campus Biomedico Di Roma
  • Local Institution - 0125
  • Local Institution - 0325
  • Local Institution - 0295
  • Local Institution - 0320
  • Local Institution - 0290
  • Local Institution - 0291
  • Local Institution - 0262
  • Local Institution - 0168
  • Local Institution - 0154
  • Local Institution - 0330
  • Local Institution - 0137
  • Local Institution - 0212
  • Local Institution - 0280
  • Local Institution - 0091
  • Local Institution - 0145
  • Local Institution - 0141
  • Local Institution - 0033
  • Local Institution - 0177
  • Local Institution - 0199
  • Local Institution - 0147
  • Local Institution - 0335
  • Local Institution - 0061
  • Local Institution - 0059
  • Local Institution - 0063
  • Local Institution - 0062
  • Local Institution - 0060
  • Local Institution - 0334
  • Local Institution - 0210
  • Local Institution - 0211
  • Local Institution - 0209
  • Local Institution - 0110
  • Local Institution - 0029
  • Local Institution - 0270
  • Local Institution - 0025
  • Local Institution - 0028
  • Local Institution - 0027
  • Local Institution - 0026
  • Local Institution
  • Local Institution - 0119
  • Local Institution
  • Local Institution - 0285
  • Local Institution
  • Local Institution - 0284
  • Local Institution - 0306
  • Local Institution
  • Local Institution - 0078
  • Local Institution - 0076
  • Local Institution - 0077
  • Local Institution - 0205
  • Local Institution - 0171
  • Local Institution - 0172
  • Local Institution - 0173
  • Local Institution - 0176
  • Local Institution - 0169
  • Local Institution - 0204
  • Local Institution - 0174
  • Local Institution - 0170
  • Local Institution - 0175
  • Local Institution - 0184
  • Local Institution - 0186
  • Local Institution - 0185
  • Local Institution - 0301
  • Local Institution - 0300
  • Local Institution - 0298
  • Local Institution - 0305
  • Local Institution - 0297
  • Local Institution - 0073
  • Local Institution - 0257
  • Local Institution - 0075
  • Local Institution - 0074
  • Local Institution - 0006
  • Local Institution - 0005

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET

Arm Description

Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice

Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice

Outcomes

Primary Outcome Measures

Pathological Complete response (pCR) using the definition of ypT0/is ypN0

Secondary Outcome Measures

pCR rate using the definition of ypT0/is ypN0 in the PDL1+ population
Residual cancer burden (RCB) category status (0, I, II, III)
RCB category status (0, I, II, III) in the PD-L1+ population
Incidence of adverse events (AEs)
Severity of AEs
Incidence of deaths

Full Information

First Posted
September 27, 2019
Last Updated
October 24, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04109066
Brief Title
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Acronym
CheckMate 7FL
Official Title
A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
January 16, 2023 (Actual)
Study Completion Date
January 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Nivolumab, Breast Cancer, Cancer, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor 2 Negative (HER2-), Neoadjuvant, Adjuvant, Primary Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
Arm Type
Experimental
Arm Description
Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice
Arm Title
Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET
Arm Type
Placebo Comparator
Arm Description
Nivolumab placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice
Intervention Type
Biological
Intervention Name(s)
nivolumab
Intervention Description
Specified Dose on Specified days
Intervention Type
Drug
Intervention Name(s)
paclitaxel (PTX)
Intervention Description
Specified dose on Specified days
Intervention Type
Other
Intervention Name(s)
nivolumab placebo
Intervention Description
Specified dose on Specified days
Intervention Type
Drug
Intervention Name(s)
anthracycline
Intervention Description
Specified dose on Specified days
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
Specified dose on Specified days
Intervention Type
Drug
Intervention Name(s)
Endocrine Therapy
Intervention Description
Variable endocrine therapy of investigators choice
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgery for breast cancer
Primary Outcome Measure Information:
Title
Pathological Complete response (pCR) using the definition of ypT0/is ypN0
Time Frame
approximately 7 months
Secondary Outcome Measure Information:
Title
pCR rate using the definition of ypT0/is ypN0 in the PDL1+ population
Time Frame
approximately 7 months
Title
Residual cancer burden (RCB) category status (0, I, II, III)
Time Frame
approximately 7 months
Title
RCB category status (0, I, II, III) in the PD-L1+ population
Time Frame
approximately 7 months
Title
Incidence of adverse events (AEs)
Time Frame
approximately 17 months
Title
Severity of AEs
Time Frame
approximately 17 months
Title
Incidence of deaths
Time Frame
approximately 17 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size > 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines. Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+. Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10% Must agree to provide primary breast tumor tissue at baseline and at surgery Must be deemed eligible for surgery Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1 Exclusion Criteria: Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time Definitive clinical or radiologic evidence of metastatic disease Multicentric BC (the presence of > 1 tumor in different quadrants of the breast) Bilateral invasive BC Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0136
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Local Institution - 0052
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Local Institution - 0051
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Local Institution - 0182
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Local Institution - 0150
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Local Institution - 0097
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution - 0149
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Local Institution - 0120
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Local Institution - 0054
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Local Institution - 0107
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution - 0056
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Local Institution - 0221
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0227
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Local Institution - 0222
City
Topsham
State/Province
Maine
ZIP/Postal Code
04086
Country
United States
Facility Name
Local Institution - 0146
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
HCA Midwest Division
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Local Institution - 0109
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Local Institution - 0050
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0180
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Local Institution - 0181
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Local Institution - 0041
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Local Institution - 0283
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0053
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Local Institution - 0218
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Local Institution - 0121
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Local Institution - 0224
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0122
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Local Institution - 0274
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 0012
City
Ciudad Autonoma Beunos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution - 0015
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Local Institution - 0294
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
X5000FHP
Country
Argentina
Facility Name
Local Institution - 0303
City
Río Cuarto
State/Province
Cordoba
ZIP/Postal Code
5800
Country
Argentina
Facility Name
Local Institution - 0011
City
Caba
State/Province
Distrito Federal
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Local Institution - 0008
City
Capital Federal
State/Province
Distrito Federal
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution - 0013
City
Ciudad Autonoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
0
Country
Argentina
Facility Name
Local Institution - 0014
City
Rosario Santa Fe
State/Province
Santa FE
ZIP/Postal Code
S2002KDS
Country
Argentina
Facility Name
Local Institution - 0020
City
Buenos Aires
ZIP/Postal Code
C1417DTB
Country
Argentina
Facility Name
Local Institution - 0021
City
Cordoba
ZIP/Postal Code
X5000BAL
Country
Argentina
Facility Name
Local Institution
City
La Rioja
Country
Argentina
Facility Name
Local Institution
City
Viedma
Country
Argentina
Facility Name
Local Institution - 0071
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Local Institution - 0069
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Local Institution - 0072
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution - 0067
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution - 0066
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0142
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution - 0070
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 0068
City
North Ballarat
State/Province
Victoria
ZIP/Postal Code
33500
Country
Australia
Facility Name
Local Institution - 0045
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0042
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution - 0048
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0046
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0047
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0187
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0030
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Local Institution - 0037
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution - 0032
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0031
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0130
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Facility Name
Local Institution - 0225
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70200-730
Country
Brazil
Facility Name
Local Institution - 0287
City
Goiânia
State/Province
Goias
ZIP/Postal Code
74605070
Country
Brazil
Facility Name
Local Institution - 0133
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Local Institution - 0132
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0288
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Local Institution - 0131
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Local Institution - 0135
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution - 0273
City
Santa Cruz do Sul
State/Province
Rio Grande Do Sul
ZIP/Postal Code
96830-180
Country
Brazil
Facility Name
Local Institution - 0134
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Local Institution - 0272
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
01229-010
Country
Brazil
Facility Name
Local Institution - 0128
City
Santo André
State/Province
São Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Local Institution - 0129
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution - 0144
City
São Paulo
ZIP/Postal Code
01317-000
Country
Brazil
Facility Name
Local Institution - 0104
City
São Paulo
ZIP/Postal Code
04378-500
Country
Brazil
Facility Name
Local Institution - 0194
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0095
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Local Institution - 0058
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution - 0197
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Local Institution - 0016
City
Santiago de Chile
State/Province
Metropolitana
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0019
City
Santiago Region Metropolitana
State/Province
Metropolitana
ZIP/Postal Code
8330034
Country
Chile
Facility Name
Local Institution - 0318
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
6900941
Country
Chile
Facility Name
Local Institution - 0018
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Local Institution - 0326
City
Antofagasta
Country
Chile
Facility Name
Local Institution - 0235
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Local Institution - 0239
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Local Institution - 0215
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Local Institution - 0319
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Local Institution - 0232
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Local Institution - 0267
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution - 0241
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution - 0312
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Facility Name
Local Institution - 0240
City
Shjiazhuang
State/Province
Hebei
ZIP/Postal Code
50051
Country
China
Facility Name
Local Institution - 0250
City
Wuhan
State/Province
Hebei
ZIP/Postal Code
430022
Country
China
Facility Name
Local Institution - 0248
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Local Institution
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Local Institution - 0255
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Local Institution - 0247
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0252
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Local Institution - 0263
City
Xian
State/Province
Shan3xi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution - 0245
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Local Institution - 0256
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Local Institution - 0214
City
YanTai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Facility Name
Local Institution - 0127
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Local Institution - 0244
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution - 0254
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution - 0311
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Local Institution - 0238
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Local Institution - 0231
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Name
Local Institution - 0237
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Local Institution - 0261
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
080020
Country
Colombia
Facility Name
Local Institution - 0203
City
Colombia
State/Province
Bogota
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0113
City
Montería
State/Province
Córdoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Local Institution - 0094
City
Bogotá
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Local Institution - 0098
City
Piedecuesta
State/Province
Santander
ZIP/Postal Code
681017
Country
Colombia
Facility Name
Local Institution - 0093
City
Cali
ZIP/Postal Code
0
Country
Colombia
Facility Name
Local Institution - 0271
City
Pereira
ZIP/Postal Code
660004
Country
Colombia
Facility Name
Local Institution - 0202
City
Rionegro
ZIP/Postal Code
054047
Country
Colombia
Facility Name
Local Institution - 0100
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 0103
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Local Institution - 0101
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Local Institution - 0099
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 0167
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Local Institution - 0165
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution - 0164
City
Kobenhavn O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution - 0166
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Local Institution - 0001
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Local Institution - 0160
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Local Institution - 0216
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72000
Country
France
Facility Name
Local Institution - 0004
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Local Institution - 0024
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Local Institution - 0162
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Local Institution - 0153
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Local Institution - 0152
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Local Institution - 0161
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Local Institution - 0195
City
Plerin
ZIP/Postal Code
22190
Country
France
Facility Name
Local Institution - 0002
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution - 0258
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Local Institution - 0228
City
Toulon Cedex
ZIP/Postal Code
83056
Country
France
Facility Name
Local Institution - 0003
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0084
City
München
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution - 0079
City
Saarbruecken
State/Province
Saarland
ZIP/Postal Code
66113
Country
Germany
Facility Name
Local Institution - 0083
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Local Institution - 0112
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 0081
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0158
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0223
City
Hamburg
ZIP/Postal Code
20259
Country
Germany
Facility Name
Local Institution - 0087
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Local Institution - 0089
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Local Institution - 0080
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0196
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution - 0111
City
Moenchengladbach
ZIP/Postal Code
41061
Country
Germany
Facility Name
Local Institution - 0156
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Local Institution - 0157
City
Velbert
ZIP/Postal Code
42551
Country
Germany
Facility Name
Local Institution - 0105
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 0115
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Facility Name
Local Institution - 0034
City
Dublin 8
State/Province
Dublin
Country
Ireland
Facility Name
Local Institution - 0036
City
Cork
Country
Ireland
Facility Name
Local Institution - 0035
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Local Institution - 0191
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Local Institution - 0207
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Federico II di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Fondazione Irccs - Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico Di Roma
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Local Institution - 0125
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution - 0325
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution - 0295
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0320
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 0290
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0291
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 0262
City
Tijuana
State/Province
BAJA California
ZIP/Postal Code
22010
Country
Mexico
Facility Name
Local Institution - 0168
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Local Institution - 0154
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0330
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0137
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Local Institution - 0212
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97125
Country
Mexico
Facility Name
Local Institution - 0280
City
Campeche
ZIP/Postal Code
24050
Country
Mexico
Facility Name
Local Institution - 0091
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Local Institution - 0145
City
Colima
ZIP/Postal Code
28018
Country
Mexico
Facility Name
Local Institution - 0141
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Local Institution - 0033
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution - 0177
City
Breda
ZIP/Postal Code
4818CK
Country
Netherlands
Facility Name
Local Institution - 0199
City
Deventer
ZIP/Postal Code
7416 SE
Country
Netherlands
Facility Name
Local Institution - 0147
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Local Institution - 0335
City
Bydgoszcz
ZIP/Postal Code
85796
Country
Poland
Facility Name
Local Institution - 0061
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Local Institution - 0059
City
Krakow
ZIP/Postal Code
30-688
Country
Poland
Facility Name
Local Institution - 0063
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Local Institution - 0062
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Facility Name
Local Institution - 0060
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0334
City
Gliwice
State/Province
Śląskie
ZIP/Postal Code
44-102
Country
Poland
Facility Name
Local Institution - 0210
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
Local Institution - 0211
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 0209
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Local Institution - 0110
City
Ponce
ZIP/Postal Code
00716-0200
Country
Puerto Rico
Facility Name
Local Institution - 0029
City
Bucharest
ZIP/Postal Code
011171
Country
Romania
Facility Name
Local Institution - 0270
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0025
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0028
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0027
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Facility Name
Local Institution - 0026
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Local Institution
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Local Institution - 0119
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Local Institution - 0285
City
Moskva
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Local Institution
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Local Institution - 0284
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Local Institution - 0306
City
Sankt-Peterburg
ZIP/Postal Code
194107
Country
Russian Federation
Facility Name
Local Institution
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Local Institution - 0078
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Local Institution - 0076
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Facility Name
Local Institution - 0077
City
Singapore
ZIP/Postal Code
308442
Country
Singapore
Facility Name
Local Institution - 0205
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Local Institution - 0171
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0172
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 0173
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution - 0176
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Local Institution - 0169
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0204
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0174
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution - 0170
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0175
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution - 0184
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution - 0186
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution - 0185
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Local Institution - 0301
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Local Institution - 0300
City
Tainan City
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Local Institution - 0298
City
Tainan
ZIP/Postal Code
70457
Country
Taiwan
Facility Name
Local Institution - 0305
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Local Institution - 0297
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0073
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Local Institution - 0257
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Facility Name
Local Institution - 0075
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Local Institution - 0074
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Local Institution - 0006
City
Withington
State/Province
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution - 0005
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

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