Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Mitogens

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Patient received paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination administered per investigators discretion

trastuzumab

pertuzumab

Norman Wolmark, MD

This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.

This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (MS) based and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. The study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.

NSABP Biospecimen Discovery Project

Breast Cancer Research Foundation

Washington University School of Medicine

NSABP Foundation Inc

Carcinoma

Adenocarcinoma

Breast Diseases

Skin Diseases

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Docetaxel

Bevacizumab

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Lenograstim

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Angiogenesis Inhibitors

Growth Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim/filgrastim

docetaxel, cyclophosphamide, and bevacizumab

bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab

bevacizumab

docetaxel 75 mg/m2 IV every 21 days for 6 cycles

docetaxel

doxorubicin 50 mg/m2 IV every 21 days for 6 cycles

doxorubicin

Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles

cyclophosphamide

pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles \[filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.\]

pegfilgrastim

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy regimen relative to the same chemotherapy without bevacizumab and relative to an anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim will be to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to TAC. The toxicities of the three regimens will also be compared.

Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens: Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group 3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing every 21 days after completion of chemotherapy until 1 year following the first dose (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors.

Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit. Submission of a tumor sample is a study requirement for all patients.

A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Genentech, Inc.

US Oncology Research

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NSABP Biospecimen Discovery Project	NCT01850628	Breast Cancer	Paclitaxel trastuzumab pertuzumab	18 Years -	NSABP Foundation Inc
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer	NCT00887536	Breast Cancer	bevacizumab docetaxel doxorubicin cyclophosphamid... pegfilgrastim	18 Years - 70 Years	NSABP Foundation Inc
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer	NCT00887536	Breast Cancer	bevacizumab docetaxel doxorubicin cyclophosphamid... pegfilgrastim	18 Years - 70 Years	NSABP Foundation Inc
NSABP Biospecimen Discovery Project	NCT01850628	Breast Cancer	Paclitaxel trastuzumab pertuzumab	18 Years -	NSABP Foundation Inc

Spots Global Cancer Trial Database for national surgical adjuvant breast and bowel project (nsabp)