MARGetuximab Or Trastuzumab (MARGOT) (MARGOT)

July 17, 2023 updated by: Adrienne G. Waks, Dana-Farber Cancer Institute

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

171

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Claudine Isaacs, MD
        • Contact:
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Principal Investigator:
          • Claudine Isaacs, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • The University of Chicago Medical Center
      • New Lenox, Illinois, United States, 60451
        • Withdrawn
        • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
      • Orland Park, Illinois, United States, 60462
        • Withdrawn
        • University of Chicago Medical Center for Advanced Care Orland Park
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02215
        • Enrolling by invitation
        • Beth Israel Deaconess Medical Center
      • Foxboro, Massachusetts, United States, 02035
        • Recruiting
        • Dana-Farber Brigham Cancer Center - Foxborough
        • Contact:
        • Principal Investigator:
          • Natalie Sinclair, MD
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Dana-Farber at Milford
        • Principal Investigator:
          • Natalie Sinclair, MD
        • Contact:
      • Weymouth, Massachusetts, United States, 02190
        • Recruiting
        • Dana-Farber at South Shore Hospital
        • Contact:
        • Principal Investigator:
          • Thomas O'Connor, MD
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Jesus Anampa, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Withdrawn
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • Active, not recruiting
        • UPMC Hillman Cancer Center - Arnold Palmer at Mountain View
      • Irwin, Pennsylvania, United States, 15642
        • Active, not recruiting
        • UPMC Hillman Cancer Center - Arnold Palmer at Norwin
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Paula Pohlmann, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine Medical Center
        • Contact:
        • Principal Investigator:
          • Mothaffar Rimawi, MD
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington Fred Hutchinson Cancer Care
        • Contact:
        • Principal Investigator:
          • Rachel Yung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Rate of pathologic complete response (pCR)
Time Frame: 12 weeks
Compare rate of pathologic complete response (pCR, defined as RCB 0) in patients with the FF or FV CD16A genotype and anatomic stage II-III HER2+ breast cancer treated with 4 cycles of neoadjuvant TMP or THP
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pathologic complete response
Time Frame: 12 weeks
Compare rate of pCR (RCB 0) in patients treated with TMP or THP, according to hormone receptor-positive (HR+) or hormone receptor-negative (HR-) status
12 weeks
Residual Cancer Burden (RCB) scores
Time Frame: 12 weeks
Assess Residual Cancer Burden (RCB) scores1 in patients treated with TMP or THP, overall and according to HR+ or HR- status. reported using the Residual Cancer Burden calculator from M.D Anderson:
12 weeks
Radiographic response rate
Time Frame: 12 Weeks

Assess radiographic response to neoadjuvant therapy in patients treated with TMP or

THP, overall and according to HR+ or HR- status.Response criteria are based on the RECIST 1.1 criteria:
12 Weeks
Number of Participants with Treatment Related Adverse Events according to CTCAE v5.0
Time Frame: From first treatment to 12 weeks
Assessment of DLTs on Arm A during the first 21 days of treatment Maximum grade of all treatment-related adverse events according to CTCAE v5.0 Patient-reported outcomes
From first treatment to 12 weeks
Event-free survival rate (EFS)
Time Frame: From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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
Time Frame: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 years
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)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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
Time Frame: up to 10 years from definitive surgery.
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Estimated)

July 1, 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 (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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