Clinical trial · Interventional
Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- docetaxel + bevacizumab + capecitabine
- description
- 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.
- interventionNames
- Biological: bevacizumab
- Drug: capecitabine
- Drug: docetaxel
Primary outcomes (1)
- measure
- Confirmed tumor response (complete or partial) rate as measured by RECIST
- timeFrame
- Up to 5 years
Secondary outcomes (2)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 proceduresReferences
Publications (1)
- RESULTPerez 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