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A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS HR+BC)

Primary Purpose

Breast Neoplasms

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Bevacizumab
Entinostat
Exemestane
Fulvestrant
Ipatasertib
Tamoxifen
Abemaciclib
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

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

Inclusion Criteria for Both Stages:

  • Measurable disease per RECIST v1.1
  • Adequate hematologic and end organ function
  • Disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor

Inclusion Criteria for Stage 1:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer
  • Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry
  • Recurrence or progression following most recent systemic breast cancer therapy
  • Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease
  • Postmenopausal according to protocol-defined criteria
  • Life expectancy >3 months
  • Available tumor specimen for determination of PD-L1 status

Inclusion Criteria for Stage 2:

  • ECOG performance status of 0-2
  • Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen

Exclusion Criteria for Both Stages:

  • Significant or uncontrolled comorbid disease as specified in the protocol
  • Uncontrolled tumor-related pain
  • Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions
  • Positive human immunodeficiency virus test
  • Active hepatitis B or C
  • Active tuberculosis
  • Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death
  • History of or known hypersensitivity to study drug or excipients
  • For patients entering Stage 2, recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent

Exclusion Criteria for Stage 1:

  • Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol
  • Unresolved AEs from prior anti-cancer therapy
  • Eligibility only for the control arm
  • Prior treatment with inhibitors as specified in the protocol

Exclusion Criteria for Stage 2:

  • Unacceptable toxicity with atezolizumab during Stage 1
  • Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol
  • Significant abdominal or intestinal manifestations within 6 months prior to treatment
  • Grade 2 or higher proteinuria

Sites / Locations

  • University of Alabama at Birmingham
  • Cedars-Sinai Medical Center
  • UCSF Helen Diller Family CCC
  • Stanford Cancer Institute
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
  • Wellness Oncology and Hematology - Main Office
  • Northwest Georgia Oncology Centers PC - Marietta
  • Rush University Medical Center - Chicago
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute
  • The Ohio State University Comprehensive Cancer Center
  • Providence Cancer Center
  • UPMC Pinnacle Health System
  • Thomas Jefferson University Hospital
  • Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
  • Sarah Cannon Research Institute
  • Houston Methodist Hospital; Department of Pharmacy
  • Northwest Medical Specialties, PLLC; Research Department
  • Rambam Medical Center
  • Shaare Zedek Medical Center
  • Rabin Medical Center-Beilinson Campus; Davidof Institute
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center; Pharmacy
  • National Cancer Center
  • Seoul National University Hospital
  • University of Ulsan College of Medicine - Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1: Fulvestrant

Stage 1: Atezolizumab + Entinostat

Stage 1: Atezolizumab + Fulvestrant

Stage 1: Atezolizumab + Ipatasertib

Stage 1: Atezolizumab + Ipatasertib + Fulvestrant

Stage 2: Atezolizumab + Bevacizumab + Endocrine Therapy

Stage 1: Mandatory On-Treatment Biopsy

Stage 1: Atezolizumab + Abemaciclib + Fulvestrant

Arm Description

Participants will receive fulvestrant until unacceptable toxicity or disease progression according to RECIST v1.1.

Participants will receive doublet combination treatment with atezolizumab plus entinostat until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Participants will receive doublet combination treatment with atezolizumab plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.

Participants will receive triplet combination treatment with atezolizumab plus ipatasertib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.

Those who progress or experience unacceptable toxicity during treatment in Stage 1 may be eligible to enter Stage 2. Participants will receive triplet combination therapy with atezolizumab plus bevacizumab plus one of three endocrine therapies (fulvestrant, exemestane, or tamoxifen) selected by the physician. Treatment in Stage 2 will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

For experimental combination arms that demonstrate clinical activity during the preliminary phase, the Sponsor may open enrollment into a separate mandatory on-treatment biopsy cohort for that combination.

Participants will receive triplet combination treatment with atezolizumab plus abemaciclib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Outcomes

Primary Outcome Measures

Percentage of Participants with Objective Response during Stage 1 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

Secondary Outcome Measures

Progression-Free Survival during Stage 1 According to RECIST v1.1
Percentage of Participants with Clinical Benefit during Stage 1 According to RECIST v1.1
Overall Survival during Stage 1
Percentage of Participants Alive at 18 Months during Stage 1
Duration of Response during Stage 1 According to RECIST v1.1
Percentage of Participants with Adverse Events (AEs) during Stage 1
Percentage of Participants with AEs during Stage 2
Atezolizumab Serum Concentration during Stage 1
Entinostat Serum and Plasma Concentration during Stage 1
Fulvestrant Plasma Concentration during Stage 1
Ipatasertib Plasma Concentration during Stage 1
Atezolizumab Serum Concentration during Stage 2
Bevacizumab Serum Concentration during Stage 2
Exemestane Plasma Concentration during Stage 2
Fulvestrant Plasma Concentration during Stage 2
Tamoxifen Plasma Concentration during Stage 2
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab during Stage 1
Percentage of Participants with ADAs to Atezolizumab during Stage 2
Percentage of Participants with ADAs to Bevacizumab during Stage 2
Abemaciclib Plasma Concentration during Stage 1

Full Information

First Posted
September 11, 2017
Last Updated
September 14, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03280563
Brief Title
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Acronym
MORPHEUS HR+BC
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 26, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

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

5. Study Description

Brief Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: Fulvestrant
Arm Type
Active Comparator
Arm Description
Participants will receive fulvestrant until unacceptable toxicity or disease progression according to RECIST v1.1.
Arm Title
Stage 1: Atezolizumab + Entinostat
Arm Type
Experimental
Arm Description
Participants will receive doublet combination treatment with atezolizumab plus entinostat until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Arm Title
Stage 1: Atezolizumab + Fulvestrant
Arm Type
Experimental
Arm Description
Participants will receive doublet combination treatment with atezolizumab plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Arm Title
Stage 1: Atezolizumab + Ipatasertib
Arm Type
Experimental
Arm Description
Participants will receive doublet combination treatment with atezolizumab plus ipatasertib until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Arm Title
Stage 1: Atezolizumab + Ipatasertib + Fulvestrant
Arm Type
Experimental
Arm Description
Participants will receive triplet combination treatment with atezolizumab plus ipatasertib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Prior to enrollment into this arm, the first 6 participants in the study will complete a safety run-in with atezolizumab plus ipatasertib.
Arm Title
Stage 2: Atezolizumab + Bevacizumab + Endocrine Therapy
Arm Type
Experimental
Arm Description
Those who progress or experience unacceptable toxicity during treatment in Stage 1 may be eligible to enter Stage 2. Participants will receive triplet combination therapy with atezolizumab plus bevacizumab plus one of three endocrine therapies (fulvestrant, exemestane, or tamoxifen) selected by the physician. Treatment in Stage 2 will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Arm Title
Stage 1: Mandatory On-Treatment Biopsy
Arm Type
Experimental
Arm Description
For experimental combination arms that demonstrate clinical activity during the preliminary phase, the Sponsor may open enrollment into a separate mandatory on-treatment biopsy cohort for that combination.
Arm Title
Stage 1: Atezolizumab + Abemaciclib + Fulvestrant
Arm Type
Experimental
Arm Description
Participants will receive triplet combination treatment with atezolizumab plus abemaciclib plus fulvestrant until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be given as 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle. This regimen will apply to all arms except when given with entinostat in Stage 1, or exemestane or tamoxifen in Stage 2, in which atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 15 of each 28-day cycle in the regimen containing fulvestrant. When given with exemestane or tamoxifen, bevacizumab will be given as 15 mg/kg via IV infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Entinostat
Intervention Description
Entinostat will be given as 5 mg orally once a week on Days 1, 8 and 15 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Exemestane
Intervention Description
Exemestane will be given as 25 mg orally QD in each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Fulvestrant will be given as 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and thereafter on Day 1 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Ipatasertib
Intervention Description
Ipatasertib will be given as 400 mg orally QD on Days 1-21 of each 28-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Intervention Description
Tamoxifen will be given as 20 mg orally QD in each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Intervention Description
Abemaciclib will be given as 150mg twice daily during each 28-day cycle.
Primary Outcome Measure Information:
Title
Percentage of Participants with Objective Response during Stage 1 According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time Frame
From baseline until disease progression or loss of clinical benefit (up to 6 years overall)
Secondary Outcome Measure Information:
Title
Progression-Free Survival during Stage 1 According to RECIST v1.1
Time Frame
From randomization until disease progression or death from any cause (up to 6 years overall)
Title
Percentage of Participants with Clinical Benefit during Stage 1 According to RECIST v1.1
Time Frame
From baseline until disease progression or loss of clinical benefit (up to 6 years overall)
Title
Overall Survival during Stage 1
Time Frame
From randomization until death from any cause (up to 6 years overall)
Title
Percentage of Participants Alive at 18 Months during Stage 1
Time Frame
18 months
Title
Duration of Response during Stage 1 According to RECIST v1.1
Time Frame
From first objective response until disease progression or death from any cause (up to 6 years overall)
Title
Percentage of Participants with Adverse Events (AEs) during Stage 1
Time Frame
From baseline until 30 days after last dose or initiation of new systemic anti-cancer therapy (up to 6 years overall)
Title
Percentage of Participants with AEs during Stage 2
Time Frame
From baseline until 30 days after last dose or initiation of new systemic anti-cancer therapy (up to 6 years overall)
Title
Atezolizumab Serum Concentration during Stage 1
Time Frame
Predose (0 hours [h]) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (cycle = 21-28 days); postdose (30 min) (infusion = 30-60 min) on Day 1 of Cycle 1; at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Entinostat Serum and Plasma Concentration during Stage 1
Time Frame
Serum predose (0 h) and plasma postdose (2-4 h) on Day 1 of Cycle 1; plasma predose (0 h) on Day 1 of Cycle 2 (cycle = 21 days)
Title
Fulvestrant Plasma Concentration during Stage 1
Time Frame
Predose (0 h) on Day 1 of Cycles 2-3 (cycle = 28 days)
Title
Ipatasertib Plasma Concentration during Stage 1
Time Frame
Predose (0 h) and postdose (1, 2, 4, 6 h) on Day 15 of Cycle 1; postdose (1-3 h) on Day 15 of Cycle 3
Title
Atezolizumab Serum Concentration during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (cycle = 21-28 days); postdose (30 min) (infusion = 30-60 min) on Day 1 of Cycle 1; at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Bevacizumab Serum Concentration during Stage 2
Time Frame
Predose (0 h) and postdose (30 min) (infusion = 30-90 min) on Day 1 of Cycles 1, 3 (cycle = 21-28 days); at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Exemestane Plasma Concentration during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycle 2 (cycle = 21 days)
Title
Fulvestrant Plasma Concentration during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycles 2-3 (cycle = 28 days)
Title
Tamoxifen Plasma Concentration during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycle 2 (cycle = 21 days)
Title
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab during Stage 1
Time Frame
Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (cycle = 28 days); at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Percentage of Participants with ADAs to Atezolizumab during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 (cycle = 21-28 days); at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Percentage of Participants with ADAs to Bevacizumab during Stage 2
Time Frame
Predose (0 h) on Day 1 of Cycles 1, 3 (cycle = 21-28 days); at treatment discontinuation (up to 6 years); and 120 days after last dose (up to 6 years overall)
Title
Abemaciclib Plasma Concentration during Stage 1
Time Frame
Predose (0 h), Postdose (30 minutes post infusion), and 4-8 hours after dose on Day 1 Cycle 1; Predose on Day 15 Cycle 1 and Day 1 of Cycles 2 and 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Both Stages: Measurable disease per RECIST v1.1 Adequate hematologic and end organ function Disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor Inclusion Criteria for Stage 1: Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry Recurrence or progression following most recent systemic breast cancer therapy Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease Postmenopausal according to protocol-defined criteria Life expectancy >3 months Available tumor specimen for determination of PD-L1 status Inclusion Criteria for Stage 2: ECOG performance status of 0-2 Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen Exclusion Criteria for Both Stages: Significant or uncontrolled comorbid disease as specified in the protocol Uncontrolled tumor-related pain Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions Positive human immunodeficiency virus test Active hepatitis B or C Active tuberculosis Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment Prior allogeneic stem cell or solid organ transplantation History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death History of or known hypersensitivity to study drug or excipients For patients entering Stage 2, recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent Exclusion Criteria for Stage 1: Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol Unresolved AEs from prior anti-cancer therapy Eligibility only for the control arm Prior treatment with inhibitors as specified in the protocol Exclusion Criteria for Stage 2: Unacceptable toxicity with atezolizumab during Stage 1 Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol Significant abdominal or intestinal manifestations within 6 months prior to treatment Grade 2 or higher proteinuria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSF Helen Diller Family CCC
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Stanford Cancer Institute
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Wellness Oncology and Hematology - Main Office
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical Center - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Providence Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97231
Country
United States
Facility Name
UPMC Pinnacle Health System
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17102
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Univ of Pittsburgh Sch of Med; Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Houston Methodist Hospital; Department of Pharmacy
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Medical Specialties, PLLC; Research Department
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus; Davidof Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center; Pharmacy
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
University of Ulsan College of Medicine - Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

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