MARGetuximab Or Trastuzumab (MARGOT) (MARGOT)

MARGetuximab Or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel/Margetuximab/Pertuzumab to Paclitaxel/Trastuzumab/Pertuzumab in Patients With Stage II-III HER2-positive Breast Cancer

The purpose of this study is to determine how well participants with stage II-III HER2-positive breast cancer respond to pre-operative treatment using one of two different combinations of drugs.

Drugs and Combinations used:

• Paclitaxel, Pertzumab and Margetuximab (Margenza)
• Paclitaxel, Pertzumab and Trastuzumab (Herceptin)

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Pertuzumab; Drug: Margetuximab; Drug: Trastuzumab

Detailed Description

This is a randomized open-label phase II trial comparing paclitaxel/margetuximab/pertuzumab (TMP) to paclitaxel/trastuzumab/pertuzumab (THP) in patients with anatomic stage II-III HER2 positive breast cancer.

• The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.

• Participants will be randomized, which means randomly assigned, to one of two treatment arms. The treatment arms in this study and the names of the study drugs in each arm are:

  • Arm A: Paclitaxel, Pertzumab and Margetuximab
  • Arm B: Paclitaxel, Pertzumab and Trastuzumab

Participants will receive study treatment for 12 weeks prior to surgery and will be followed for 10 years after surgery. After surgery, some participants will continue to receive the study drug margetuximab for a year in total, if they respond very well to the first 12 weeks of treatment with margetuximab.

It is expected that about 171 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease. "Investigational" means that the drug combination is being studied.

The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab (Herceptin), and pertuzumab as part of a pre-operative treatment option for stage II-III HER2-positive breast cancer.

The U.S. Food and Drug Administration (FDA) has approved margetuximab (Margenza) for advanced HER2-positive breast cancer.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Georgetown University Medical Center
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Foxborough, Massachusetts, United States, 02035
      • Dana-Farber Brigham Cancer Center - Foxborough
    • Milford, Massachusetts, United States, 01757
      • Dana-Farber at Milford
    • Weymouth, Massachusetts, United States, 02190
      • Dana-Farber at South Shore Hospital
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • Pennsylvania
    • Greensburg, Pennsylvania, United States, 15601
      • UPMC Hillman Cancer Center - Arnold Palmer at Mountain View
    • Irwin, Pennsylvania, United States, 15642
      • UPMC Hillman Cancer Center - Arnold Palmer at Norwin
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine Medical Center
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington Fred Hutchinson Cancer Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm (in breast mass or axillary lymph node) determined by physical exam or imaging (whichever is larger) is required. Patients with inflammatory breast carcinoma (T4d) are NOT eligible.
• Centrally confirmed to have a low affinity CD16 germline genotype (FF or FV)
• HER-2 positive by 2018 American Society of Clinical Oncology/College of American Pathologists criteria, as assessed by standard institutional guidelines (central testing is not required).
• ER/PR determination is required. ER- and PR-assays should be performed by immunohistochemical methods according to standard institutional guidelines
• Bilateral breast cancers are allowed as long as both cancers are HER2-positive (as defined in 3.1.2), or the contralateral cancer is a <1 cm, ER+ tumor.
• Patients with multifocal or multicentric disease are eligible if the treating investigator hasdetermined the patient should be treated as HER2-positive.
• Breast imaging should include dedicated ultrasound of the ipsilateral axilla. For subjects with a clinically positive axilla based on exam or imaging, a fine needle aspiration or core biopsy procedure will be performed to determine the presence of metastatic disease in the lymph nodes (though lymph node sampling procedure need not be resulted prior to patient's registration on trial, as long as all other eligibility are met).
• Men and women (with any menopausal status) ≥18 years of age are eligible.
• ECOG performance status 0 or 1

• Required laboratory values demonstrating adequate organ function:

  • ANC ≥ 1000/mm3
  • Hemoglobin ≥ 9 g/dl
  • Platelets ≥ 100,000/mm3
  • Serum creatinine < 1.5 x ULN (institutional) OR calculated GFR ≥ 60mL/min
  • Total bilirubin ≤ 1.5 x ULN (institutional). For patients with Gilbert Syndrome, the direct bilirubin should be within the institutional normal range OR total bilirubin ≤ 2.0 mg/dL.
  • AST and ALT ≤ 2.5x ULN (institutional) Left ventricular ejection fraction (LVEF) ≥ 50%.
• Women of childbearing potential must have a negative serum pregnancy test within 14 days of treatment start. Childbearing potential is defined as: those who have not been surgically sterilized and/or have had a menstrual period in the past 12 months
• Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment.
• Patients with a history of ipsilateral or contralateral DCIS or LCIS are eligible.
• Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy.
• Non-English-speaking patients are eligible but will be exempt from patient-completed questionnaires.
• Willing and able to sign informed consent.
• Willing to undergo breast biopsy for research purposes.

Exclusion Criteria:

• Pregnant or nursing women due to the teratogenic potential of the study drugs.
• Active, unresolved infection requiring intervention
• Receipt of intravenous antibiotics for infection within 7 days prior to registration.
• Uncontrolled hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Class II or higher, or serious cardiac arrhythmia requiring medication.
• Significant symptoms (Grade ≥ 2) from peripheral neuropathy.
• Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.
• Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation, or experimental therapy.
• Patients with any prior history of invasive breast cancer within the past 5 years are not eligible. Non-metastatic invasive breast cancers diagnosed more than 5 years ago and any other type of prior non-metastatic cancer is allowed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paclitaxel + Pertuzumab + Margetuximab; The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days; Paclitaxel- via IV, Day 1,8,15 of each cycle; Margetuximab via IV, Day 1 of each cycle; Pertuzumab via IV, Day 1 of each cycle	Drug: Paclitaxel; Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.; Other Names: Taxol; Onxal; Drug: Pertuzumab; Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.; Other Names: Perjeta; Drug: Margetuximab; Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.; Other Names: Margenza
Experimental: Paclitaxel + Pertuzumab + Trastuzumab; The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days; Paclitaxel- via IV, Day 1,8,15 of each cycle; Pertuzumab via IV, Day 1 of each cycle; Trastuzumab via IV, Day 1 of each cycle	Drug: Paclitaxel; Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.; Other Names: Taxol; Onxal; Drug: Pertuzumab; Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.; Other Names: Perjeta; Drug: Trastuzumab; Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.; Other Names: Herceptin; Herzuma; Ogivri; Kanjinti

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic Complete Response (pCR)	Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Pathologic Complete Response in Hormone Receptor Positive (HR+) Subjects	In hormone receptor positive (HR+) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.	12 weeks
Rate of Pathologic Complete Response in Hormone Receptor Negative (HR-) Subjects	In hormone receptor negative (HR-) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.	12 weeks
Residual Cancer Burden (RCB) Scores	Assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.	12 weeks
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects	Among hormone receptor positive (HR+) patients, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson.	12 weeks
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects	Among hormone receptor negative (HR-) subjects, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.	12 weeks
Dose-limiting Toxicities (DLTs) in theTMP Arm (Paclitaxel/Margetuximab/Pertuzumab) During the First 21 Days of Treatment	Among the subjects treated with TMP (Paclitaxel/Margetuximab/Pertuzumab), report the number of subjects with dose-limiting toxicities (DLTs) during the first 21 days of treatment, where 21 days equals one cycle of treatment. DLTs are defined in Section 5.4 of the protocol, with the specified toxicities and lab values categorized and graded according to CTCAE v5.0.	From first treatment to 21 days
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment	Maximum grade of all treatment-related adverse events (TRAEs) according to CTCAE v5.0 during neoadjuvant treatment, recorded per patient per arm. Subjects with no TRAEs reported (Grade 0) and Grade 1 adverse events are combined into a single category because only adverse events of Grade 2 or more were consistently reported.	Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Patient-reported Outcomes	Patient-reported outcomes for symptoms and quality of life (both physical and mental health) during neoadjuvant TMP and THP	From first treatment to 12 weeks
Event-free Survival Rate (EFS)	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS) Patients With RCB 0 or 1	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS)Patients With RCB 2 or 3	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant TMP	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS) Patients Randomized to Neoadjuvant THP	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS) -Patients With pCR	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Event-free Survival Rate (EFS) -Patients Without pCR	The distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI)	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) RCB 0 or 1	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) RCB 2 or 3	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant TMP	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) Patients Randomized to Neoadjuvant THP	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) Patients With pCR	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 years
Recurrence-free Interval Rate (RFI) Patients Without pCR	The distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
Overall Survival Rate (OS)	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Patients With RCB 0 or 1	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Patients With RCB 2 or 3	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Patients Randomized to Neoadjuvant TMP	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Randomized to Neoadjuvant THP	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Patients With pCR	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.
Overall Survival Rate (OS) Patients Without CR	The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error	up to 10 years from definitive surgery.

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: MacroGenics; Translational Breast Cancer Research Consortium
• Investigators: Principal Investigator: Adrienne Waks, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Actual): October 24, 2024
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer; HER2-positive Breast Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Diterpenes; Trastuzumab; Paclitaxel; pertuzumab; Ogivri; margetuximab
• Other Study ID Numbers: 20-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No