Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

NCT00088998 | Completed Phase 2

• 3 other identifiers: NCCTG-N0432NCI-2012-02617CDR0000377886
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Confirmed tumor response (complete or partial) rate as measured by RECIST

  Up to 5 years

Secondary Outcomes (2)

• Progression-free survival

  Up to 5 years

• Overall survival

  Up to 5 years

Study Arms (1)

docetaxel + bevacizumab + capecitabine

EXPERIMENTAL

Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

Biological: bevacizumab; Drug: capecitabine; Drug: docetaxel

Interventions

bevacizumab BIOLOGICAL

docetaxel + bevacizumab + capecitabine

capecitabine DRUG

docetaxel + bevacizumab + capecitabine

docetaxel DRUG

docetaxel + bevacizumab + capecitabine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive breast cancer * Clinical evidence of metastatic disease * No bone metastases as the only evidence of metastasis * Measurable disease * At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan * Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung * Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes) * Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Inflammatory breast disease * Lymphangitis cutis or pulmonis * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated * Prior breast cancer allowed * No prior or active brain metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL * No bleeding diathesis or uncontrolled coagulopathy Hepatic * Bilirubin normal * Meets 1 of the following criteria: * AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN) * AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN * AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal Renal * Creatinine clearance ≥ 30 mL/min * No proteinuria OR * Protein \< 1 g by 24-hour urine collection * No nephrotic syndrome Cardiovascular * No uncontrolled hypertension (i.e., blood pressure \> 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart) * Blood pressure \< 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication * No atrial or venous thrombosis within the past month * No clinically significant heart disease, including any of the following: * Congestive heart failure * Symptomatic coronary artery disease * Uncontrolled cardiac arrhythmias * Unstable angina * No myocardial infarction within the past 12 months * No history of cerebrovascular accident Pulmonary * No hemoptysis within the past 6 months Gastrointestinal * No lack of physical integrity of the upper gastrointestinal tract * No malabsorption syndrome * Able to receive oral medication Other * No other stage III or IV invasive malignancy requiring treatment within the past 5 years * No pre-existing peripheral neuropathy \> grade 1 * No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80 * No prior severe reaction to fluoropyrimidines * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No active infection * No significant medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No other concurrent biologic therapy Chemotherapy * Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease * No prior chemotherapy for metastatic disease * More than 4 weeks since prior cytotoxic chemotherapy * More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel) * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting Radiotherapy * See Disease Characteristics * More than 4 weeks since prior radiotherapy to a target lesion * Prior single-dose palliative radiotherapy allowed within the past 4 weeks * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery Other * More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents * Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed * More than 4 weeks since prior investigational agents * No concurrent aspirin, anticoagulants, or thrombolytic agents * No concurrent participation in another clinical trial involving investigational agents or procedures

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Perez EA, Hillman DW, Dentchev T, Le-Lindqwister NA, Geeraerts LH, Fitch TR, Liu H, Graham DL, Kahanic SP, Gross HM, Patel TA, Palmieri FM, Dueck AC. North Central Cancer Treatment Group (NCCTG) N0432: phase II trial of docetaxel with capecitabine and bevacizumab as first-line chemotherapy for patients with metastatic breast cancer. Ann Oncol. 2010 Feb;21(2):269-274. doi: 10.1093/annonc/mdp512. Epub 2009 Nov 9.

  PMID: 19901014 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Bevacizumab; 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; 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; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Edith A. Perez, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: December 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: December 1, 2010
• Last Updated: December 7, 2016

Record last verified: 2016-12