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Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

NCT00446030•Sanofi

View on ClinicalTrials.gov

Summary

This is a phase II, open-label, multicenter, pilot study of the safety and efficacy of two Docetaxel-based regimens plus bevacizumab for the adjuvant treatment of participants with node positive or high risk node negative breast cancer. The primary objective of this study was to evaluate the cardiac safety, and the secondary objectives were to evaluate safety and toxicity of participants treated with bevacizumab ± trastuzumab administered with 2 different docetaxel-based combination regimens. This study was originally designed to also evaluate disease-free survival (DFS) and overall survival (OS); however, based on a protocol amendment, follow-up was shortened from 10 years to 2 years, and the efficacy endpoints of disease free survival and overall survival were deleted from the protocol.

Eligibility

Age

18 - 70 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants who met the following criteria were eligible for this study:
•1. Woman aged 18 to 70 years, inclusive
•2. Had histologically proven breast cancer with the most recent surgery done for breast cancer up to 60 days prior to study registration
•3. Had definitive surgical treatment - either mastectomy, or breast conserving surgery with axillary lymph node dissection (or sentinel lymph node biopsy) for operable breast cancer (T1-3, clinical N0-1, and M0)
•4. Must have been either "lymph node positive" or "high risk lymph node negative"
•1. Were lymph node positive participants who had at least 1 axillary lymph node involved by breast cancer. (with lymph node metastasis \>0.2 mm)
•2. Were high risk lymph node negative participants had no lymph node involvement and at least 1 of the following factors:
•* tumor size \>2 cm
•* estrogen receptor (ER) and progesterone receptor (PR) status negative
•* histologic and/or nuclear Grade 2/3
+16 more criteria

Exclusion Criteria

•Participants with the following criteria were excluded from this study:
•1. Had prior systemic anticancer therapy for invasive breast cancer (immunotherapy,hormonotherapy, chemotherapy)
•2. Had prior anthracycline therapy, taxoids, or platinum salts for any malignancy
•3. Had prior radiation therapy for breast cancer or any radiotherapy to the chest wall for any other malignancy
•4. Was pregnant or lactating
•5. Had pre-existing motor or sensory neurotoxicity of a severity \>Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 3.0
•6. Had cardiac disease or risk for same as follows:
•* Any documented myocardial infarction
•* Angina pectoris that required the use of anti-anginal medication
•* Any history of documented congestive heart failure
+36 more criteria

Locations (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Key Dates

Start Date

March 1, 2007

Primary Completion Date

August 1, 2010

Completion Date

August 1, 2010

Last Updated

June 26, 2012

Enrollment

127

ACTUAL participants

Conditions

Breast Neoplasms

Interventions

Docetaxel

DRUG

Doxorubicin

DRUG

Carboplatin

DRUG

Cyclophosphamide

DRUG

Trastuzumab

DRUG

Bevacizumab

DRUG

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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RECRUITINGPHASE3

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

NCT06312176

Breast Neoplasms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 26, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

Dissemination of BREASTChoice AIM1-B

Role of Sodium-glucose Linked Transporter 2 (SGLT2) and Its Inhibitor Over CARdiotoxicity Induced by Anthracyclines and Breast Cancer Tumorigenesis SCARA-B