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Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer (PELICAN)

Primary Purpose

Inflammatory Breast Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab Injection
neoadjuvant EC-paclitaxel chemotherapy
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  1. Male/female participants who are at least 18 years of age on the day of signing informed consent
  2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Evaluation of ECOG is to be performed within 7 days prior to the date of randomization. Note: may consider ECOG PS 2 if good rationale provided and discussed with Sponsor team.
  3. Able to comply with the protocol,
  4. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen, or any other regimen of social security
  5. Patient (or legally acceptable representative if applicable) has provided written informed consent for the trial,
  6. Previously untreated, histologically confirmed diagnosis of breast cancer and confirmed inflammatory breast cancer defined as follows:

    - T4d any N following American Joint Committee on Cancer (AJCC)-8th version classification: breast erythema, edema and/or peau d'orange, occupying at least 1/3 of the breast, with or without underlying palpable mass, duration of history of no more than 6 months.

  7. HER2 negative tumors by immunohistochemistry (IHC 0 or 1+) or fluorescent/chromogenic in situ hybridization (FISH- or CISH-)
  8. Hormone receptors status known,
  9. No metastases,
  10. Have adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
  11. Adequate hematologic function: absolute neutrophil count ≥ 1.5 x 109/L AND platelets ≥ 100 x 109 AND Hb ≥ 9.0 g/dL or ≥5.6 mmol/L, Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
  12. Adequate liver function: total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AND - ASAT ≤ 2.5 ULN AND ALAT ≤ 2.5 ULN,
  13. Adequate kidney function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 × institutional ULN, Creatinine clearance (CrCl) should be calculated per institutional standard.
  14. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 ULN unless subject is receiving anticoagulant therapy, as long as PT or TCA is within therapeutic range of intended use of the anticoagulants,
  15. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% (isotopic or ultrasound methods),
  16. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 months after the last dose of cyclophosphamide and 4 months after the last dose of pembrolizumab, whichever come last.

    Note: Abstinence is acceptable if this is the established and preferred contraception for the subject

  17. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period (corresponding to time needed to eliminate any study treatments plus an additional 120 days (a spermatogenesis cycle) for study treatments with risk of genotoxicity at any dose).

Exclusion Criteria:

  1. Has metastatic breast cancer,
  2. Has HER2-positive breast cancer,
  3. Has bilateral breast cancer
  4. Prior allogeneic stem cell or solid organ transplantation
  5. A WOCBP who has a positive serum pregnancy test within 72 hours prior to randomiza-tion
  6. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment, Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  7. Has known active CNS disease or carcinomatous meningitis.
  8. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug,
  9. Has a known history of active TB (Bacillus Tuberculosis),
  10. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients,
  11. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy,
  12. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  13. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment,
  14. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis,
  15. Has an active infection requiring systemic therapy.
  16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator,
  17. Has known psychiatric or substance abuse disorders that would interfere with coopera-tion with the requirements of the trial,
  18. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment,
  19. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).,
  20. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies),
  21. Has known history of Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C virus infection (e.g., HCV RNA [qualitative] is detected)
  22. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.

Sites / Locations

  • Sint-Augustinus Hospital
  • Jules Bordet
  • Grand Hôpital de Charleroi
  • UZ Gand
  • UCL
  • CHU Ambroise Pare
  • Saint Elisabeth
  • Clinique de L'EuropeRecruiting
  • Institut Sainte CatherineRecruiting
  • Institut BERGONIERecruiting
  • CENTRE Francois BaclesseRecruiting
  • Centre Leon BerardRecruiting
  • Institut CurieRecruiting
  • Centre Henri BecquerelRecruiting
  • Institut Curie hopital rene hugueninRecruiting
  • Institut de cancérologie de la loireRecruiting
  • Centre Paul StraussRecruiting
  • IUCT-Oncopole Institut Claudius RigaudRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab

Standard neoadjuvant chemotherapy

Arm Description

EC Paclitaxel + Pembrolizumab Injection

EC Paclitaxel alone

Outcomes

Primary Outcome Measures

Central evaluation of pathological complete response rate
absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)
Dose Limiting Toxicity (DLT) rates
incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-). DLTs will be defined according to CTCAE.

Secondary Outcome Measures

occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period)
according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Local evaluation of pathological complete response rate
defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)
Invasive disease-free survival (IDFS)
time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
Invasive disease-free survival (IDFS)
time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
Event free survival (EFS)
time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)
Event free survival (EFS)
time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)
Overall survival (OS)
time from randomization to death from any cause
Overall survival (OS)
time from randomization to death from any cause

Full Information

First Posted
March 23, 2018
Last Updated
June 30, 2020
Sponsor
Institut Paoli-Calmettes
Collaborators
MSD France, Oncodistinct
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1. Study Identification

Unique Protocol Identification Number
NCT03515798
Brief Title
Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
Acronym
PELICAN
Official Title
A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
Collaborators
MSD France, Oncodistinct

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.
Detailed Description
Inflammatory breast cancer (IBC) is a rare and highly aggressive subtype of locally advanced breast cancer representing approximately 5% of all breast cancers that requires immediate aggressive treatment. Significant progress has been made in recent years using a combination of treatments, including neoadjuvant chemotherapy, surgery and radiation therapy. Accumulating data indicate a prognostic and/or predictive impact for immune-response variables in BC. Recent data, suggest that PD-L1 is overexpressed in a significant number of BC, notably in IBC and may have significant prognostic or predictive value. Furthermore it may be targeted to restore or boost functional antitumor immunity. Pembrolizumab, a PD-1-directed monoclonal antibody is already registered and has an out-standing activity in advanced melanoma and NSCLC patients, with promising results in several other tumor types, including triple-negative BC, and a favorable profile of tolerance. Thus, potential benefits of pembrolizumab in combination with a conventional cytotoxic backbone may be considered as high in HER2-negative IBC. The aim of the study is to assess the pathological complete response rate following neoadjuvant EC-paclitaxel chemotherapy plus pembrolizumab and to assess if neoadjuvant chemotherapy with anthracycline-based induction in combination with pembrolizumab exposes IBC patients to significant toxicity. rates.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab
Arm Type
Experimental
Arm Description
EC Paclitaxel + Pembrolizumab Injection
Arm Title
Standard neoadjuvant chemotherapy
Arm Type
Active Comparator
Arm Description
EC Paclitaxel alone
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab Injection
Other Intervention Name(s)
MK3475
Intervention Description
Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks
Intervention Type
Drug
Intervention Name(s)
neoadjuvant EC-paclitaxel chemotherapy
Other Intervention Name(s)
Epirubicine, Cyclophosphamide, Paclitaxel
Intervention Description
The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
Primary Outcome Measure Information:
Title
Central evaluation of pathological complete response rate
Description
absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
Title
Dose Limiting Toxicity (DLT) rates
Description
incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-). DLTs will be defined according to CTCAE.
Time Frame
during 21 days following the first administration of pembrolizumab
Secondary Outcome Measure Information:
Title
occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period)
Description
according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time Frame
during 21 days following the first administration of pembrolizumab
Title
Local evaluation of pathological complete response rate
Description
defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system)
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
Title
Invasive disease-free survival (IDFS)
Description
time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
Time Frame
3 years
Title
Invasive disease-free survival (IDFS)
Description
time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause
Time Frame
5 years
Title
Event free survival (EFS)
Description
time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)
Time Frame
3 years
Title
Event free survival (EFS)
Description
time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)
Time Frame
5 years
Title
Overall survival (OS)
Description
time from randomization to death from any cause
Time Frame
3 years
Title
Overall survival (OS)
Description
time from randomization to death from any cause
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Evaluation of PD-L1 expression in pre, per and post-treatment tissue
Description
by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
Title
Measurement of baseline Circulating tumor cells for prospective validation of their prognostic value in IBC
Description
Measurement of baseline CTC for prospective validation of their prognostic value in IBC
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
Title
Disease monitoring
Description
Purification of ctDNA and specific sequencing for disease monitoring.
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
Title
Identification of mechanisms of treatment resistance
Description
Immune profiling, NGS and mouse xenografing for ex-vivo phenotypic approaches on post-treatment residual disease in order to identify mechanisms of resistance.
Time Frame
Following completion of neoadjuvant systemic treatment, an average of 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male/female participants who are at least 18 years of age on the day of signing informed consent Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Evaluation of ECOG is to be performed within 7 days prior to the date of randomization. Note: may consider ECOG PS 2 if good rationale provided and discussed with Sponsor team. Able to comply with the protocol, Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen, or any other regimen of social security Patient (or legally acceptable representative if applicable) has provided written informed consent for the trial, Previously untreated, histologically confirmed diagnosis of breast cancer and confirmed inflammatory breast cancer defined as follows: - T4d any N following American Joint Committee on Cancer (AJCC)-8th version classification: breast erythema, edema and/or peau d'orange, occupying at least 1/3 of the breast, with or without underlying palpable mass, duration of history of no more than 6 months. HER2 negative tumors by immunohistochemistry (IHC 0 or 1+) or fluorescent/chromogenic in situ hybridization (FISH- or CISH-) Hormone receptors status known, No metastases, Have adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment. Adequate hematologic function: absolute neutrophil count ≥ 1.5 x 109/L AND platelets ≥ 100 x 109 AND Hb ≥ 9.0 g/dL or ≥5.6 mmol/L, Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. Adequate liver function: total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AND - ASAT ≤ 2.5 ULN AND ALAT ≤ 2.5 ULN, Adequate kidney function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 × institutional ULN, Creatinine clearance (CrCl) should be calculated per institutional standard. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 ULN unless subject is receiving anticoagulant therapy, as long as PT or TCA is within therapeutic range of intended use of the anticoagulants, Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% (isotopic or ultrasound methods), A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 months after the last dose of cyclophosphamide and 4 months after the last dose of pembrolizumab, whichever come last. Note: Abstinence is acceptable if this is the established and preferred contraception for the subject A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period (corresponding to time needed to eliminate any study treatments plus an additional 120 days (a spermatogenesis cycle) for study treatments with risk of genotoxicity at any dose). Exclusion Criteria: Has metastatic breast cancer, Has HER2-positive breast cancer, Has bilateral breast cancer Prior allogeneic stem cell or solid organ transplantation A WOCBP who has a positive serum pregnancy test within 72 hours prior to randomiza-tion Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment, Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. Has known active CNS disease or carcinomatous meningitis. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, Has a known history of active TB (Bacillus Tuberculosis), Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy, Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment, Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis, Has an active infection requiring systemic therapy. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, Has known psychiatric or substance abuse disorders that would interfere with coopera-tion with the requirements of the trial, Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment, Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)., Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), Has known history of Hepatitis B (e.g., HBsAg reactive) or known active Hepatitis C virus infection (e.g., HCV RNA [qualitative] is detected) Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique GENRE, MD
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Margot Berline
Phone
33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Goncalves, Pr
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint-Augustinus Hospital
City
Antwerp
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Dirix
First Name & Middle Initial & Last Name & Degree
Dirix
Facility Name
Jules Bordet
City
Bruxelles
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Awada, Dr
First Name & Middle Initial & Last Name & Degree
Ahmad Awada, Dr
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc Canon
First Name & Middle Initial & Last Name & Degree
Canon
Facility Name
UZ Gand
City
Gand
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannelore Denys
First Name & Middle Initial & Last Name & Degree
Denys
Facility Name
UCL
City
Louvain
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Duhoux
First Name & Middle Initial & Last Name & Degree
Duhoux
Facility Name
CHU Ambroise Pare
City
Mons
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Holbrechts
First Name & Middle Initial & Last Name & Degree
Holbrechts
Facility Name
Saint Elisabeth
City
Namur
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Vuysteke
First Name & Middle Initial & Last Name & Degree
Vuysteke
Facility Name
Clinique de L'Europe
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GOZY
First Name & Middle Initial & Last Name & Degree
GOZY, Dr
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien GRENIER, Dr
First Name & Middle Initial & Last Name & Degree
Julien GRENIER, Dr
Facility Name
Institut BERGONIE
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille CHAKIBA-BRUGERE, Dr
First Name & Middle Initial & Last Name & Degree
Camille CHAKIBA-BRUGERE, Dr
Facility Name
CENTRE Francois Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle LEVY, Dr
First Name & Middle Initial & Last Name & Degree
Christelle LEVY
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas BACHELOT, Dr
First Name & Middle Initial & Last Name & Degree
Thomas BACHELOT, Dr
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence LEREBOURS, Dr
First Name & Middle Initial & Last Name & Degree
Florence Lerebours, Dr
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne LEHEURTEUR, Dr
First Name & Middle Initial & Last Name & Degree
Marianne LEHEURTEUR, Dr
Facility Name
Institut Curie hopital rene huguenin
City
Saint-Cloud
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence Lerebours, Dr
First Name & Middle Initial & Last Name & Degree
Florence Lerebours
Facility Name
Institut de cancérologie de la loire
City
Saint-Priest-en-Jarez
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe JACQUIN, Pr
First Name & Middle Initial & Last Name & Degree
Jean-Philippe JACQUIN, Pr
Facility Name
Centre Paul Strauss
City
Strasbourg
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thierry PETIT, Pr
First Name & Middle Initial & Last Name & Degree
Thierry PETIT, Pr
Facility Name
IUCT-Oncopole Institut Claudius Rigaud
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence DALENC, Dr
First Name & Middle Initial & Last Name & Degree
Florence DALENC, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
28564564
Citation
Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.
Results Reference
background
Citation
Binder-Foucard F, Rasamimanana Cerf N, Belot A, Bossard N. Estimation nationale de l'incidence et de la mortalité par cancer en France entre 1980 et 2012. Étude à partir des registres des cancers du réseau Francim. Partie 1 - Tumeurs solides-Synthèse. In: http://www.invs.sante.fr. 2013.
Results Reference
background
PubMed Identifier
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Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer

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