Therapy With Bevacizumab (BEV), Doxorubicin, and Cyclophosphamide Followed by BEV, Docetaxel, and Capecitabine Before Surgery Followed by BEV Alone After Surgery for Women With Locally Advanced Breast Cancer

NCT00365417 | Completed Phase 2 Results

• 1 other identifier: NSABP FB-4
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:

• How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors
• Side effects from adding bevacizumab to chemotherapy
• Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart
• If receiving bevacizumab will have any effect on how patients recover from surgery
• Side effects of the combinations of drugs used in this study

Conditions

Breast Cancer

Keywords

NSABP; Doxorubicin; Cyclophosphamide; Bevacizumab; Capecitabine; Docetaxel; Breast cancer; Locally advanced; Neoadjuvant; Locally advanced breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response (pCR) in the Breast

  Measured by no histologic evidence of invasive tumor cells in the surgical breast specimen

  Approximately 7 months

Secondary Outcomes (7)

• pCR in the Breast and Nodes

  Approximately 7 months

• Clinical Response Rate (cRR) of the Sequential Regimen

  Approximately 6 months

• Reported Adverse Events

  Approximately 14 months

• Cardiac Events

  Assessments throughout; up to 18 months following study entry

• Progression-free Survival

  2 years

Study Arms (1)

Doxorubicin+Cyclophosphamide+Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Capecitabine; Drug: Docetaxel

Interventions

Bevacizumab DRUG

15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles

Also known as: Avastin

Doxorubicin+Cyclophosphamide+Bevacizumab

Doxorubicin DRUG

60 mg/m\^2 IV every 21 days x 4 cycles

Doxorubicin+Cyclophosphamide+Bevacizumab

Cyclophosphamide DRUG

600 mg/m\^2 IV every 21 days x 4 cycles

Doxorubicin+Cyclophosphamide+Bevacizumab

Capecitabine DRUG

Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles

Also known as: Xeloda

Doxorubicin+Cyclophosphamide+Bevacizumab

Docetaxel DRUG

Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles

Also known as: Taxotere

Doxorubicin+Cyclophosphamide+Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be female.
• The patient must be greater than/equal to 18 years old
• The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
• Patients must have clinical Stage IIIA, IIIB, or IIIC disease (American Joint Committee on Cancer \[AJCC\] staging criteria) with a primary breast tumor that is greater than/equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.
• Patients must have the ability to swallow oral medication.
• The patient's Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.
• At the time of study entry, blood counts must meet the following criteria:
• Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.
• Platelet count must be greater than/equal to 100,000/mm\^3.
• Hemoglobin must be greater than/equal to 10 g/dL.
• The following criteria for evidence of adequate hepatic function must be met:
• total bilirubin must be less than/equal to upper limit of normal (ULN) for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
• alkaline phosphatase must be less than 2.5 x ULN for the lab; and
• aspartate aminotransferase (AST) must be less than/equal to 1.5 x ULN for the lab.
• Alkaline phosphatase and AST may not both be greater than the ULN. For example, if the alkaline phosphatase is greater than the ULN but less than/equal to 2.5 x ULN, then the AST must be less than/equal to the ULN. If the AST is greater than the ULN but less than/equal to 1.5 x ULN, then the alkaline phosphatase must be less than/equal to ULN.

You may not qualify if:

• Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification).
• Excisional biopsy for this primary tumor.
• Synchronous bilateral invasive breast cancer.
• Surgical axillary staging procedure prior to study entry (Exceptions: 1) fine needle aspiration (FNA) of an axillary node is permitted for any patient, and 2) although not recommended, a sentinel lymph node biopsy for patients with clinically negative axillary nodes is permitted.)
• History of any of the following cancers:
• Ipsilateral breast cancer: invasive, ductal carcinoma in situ (DCIS) treated with any therapy other than excision
• Contralateral breast cancer: invasive within the past 5 years (Patients with history of DCIS or synchronous DCIS are eligible)
• History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Prior therapy with anthracyclines, taxanes, capecitabine, or bevacizumab for any malignancy.
• Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before study entry and be re-started, if indicated, following chemotherapy.
• Any of the following cardiac conditions:
• angina pectoris that requires the use of anti-anginal medication;
• history of documented congestive heart failure;
• serious cardiac arrhythmia requiring medication;
• severe conduction abnormality;

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• Genentech, Inc.: collaborator
• Hoffmann-La Roche: collaborator
• International Drug Development Institute: collaborator

Study Sites (1)

NSABP Foundation, Inc.

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Doxorubicin; Cyclophosphamide; Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Results Point of Contact

• Title: Diana Gosik
• Organization: NSABP Foundation, Inc.

diana.gosik@nsabp.org

412-339-5333

Study Officials

• Norman Wolmark, MD

  NSABP Foundation Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2006
• First Posted: August 17, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: November 1, 2009
• Last Updated: April 13, 2021
• Results First Posted: August 12, 2010

Record last verified: 2020-03

Locations

US (1)