A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
N/A
N/A
Female
brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
Trial Information
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
OBJECTIVES:
Primary
- Compare the safety and effectiveness of carboplatin vs docetaxel in women with
metastatic breast cancer and the BRCA1 or BRCA2 gene mutation.
Secondary
- Compare time to disease progression in patients treated with these regimens.
- Compare progression-free survival of patients treated with carboplatin vs docetaxel.
OUTLINE: This is a randomized, open-label, multicenter, pilot study. Patients are stratified
according to gene mutation (BRCA1 vs BRCA2), prior adjuvant taxane chemotherapy (yes vs no),
liver or lung metastasis affecting the parenchyma (yes vs no), Jewish ancestry by parent or
grandparent (yes vs no), and first-line treatment vs second-line treatment. Patients are
randomized to 1 of 2 treatment arms.
- Arm I: Patients receive carboplatin IV over 1 hour on day 1.
- Arm 2: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with disease progression after 3 or 6 courses of
treatment may crossover to the alternative treatment arm. If progression is present
after 3 courses in the crossover arm, patients may receive further treatment at the
discretion of their oncologist. Patients responding to and tolerating treatment well,
may be given 2 further courses in accordance with local center policy, although this is
not encouraged.
Patients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or
21 days.
After completion of study treatment, patients are followed periodically for survival.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- BRCA1 or BRCA2 mutation carrier
- Metastatic disease
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques or ≥ 10 mm by spiral CT scan
- Stable, treated brain metastases allowed provided other sites of measurable disease
are present
- Patients with bone metastases who are currently receiving bisphosphonates for
palliation are eligible provided other sites of measurable disease are present
- Patients who have not received anthracycline-based chemotherapy in the adjuvant
setting may receive a non-taxane, anthracycline regimen as the first-line metastatic
treatment and enter the trial at confirmed progression (second-line)
- No bone-limited disease
- No disease suitable for endocrine therapy alone
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Sex: female
- WHO performance status 0-2
- Life expectancy ≥ 3 months
- AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase > 5
times ULN)
- Glomerular filtration rate ≥ 30 mL/min
- Normal urea and creatinine
- Normal hematological and biochemical studies
- Normal bilirubin
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment
- Negative pregnancy test
- No known allergy to platinum compounds or mannitol
- No known sensitivity to taxanes
- No other malignancy within the past 10 years except adequately treated in situ
carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
- No sensory or motor neuropathy > grade 1
- No other serious uncontrolled medical conditions or concurrent medical illness that
would preclude study compliance
- No contraindication to chemotherapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 12 months since prior taxane therapy
- No prior chemotherapy with a platinum drug, unless treatment was for a non-breast
cancer-related disease more than 10 years ago
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response and toxicity
Safety Issue:
Yes
Principal Investigator
Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Guy's Hospital
Authority:
Unspecified
Study ID:
CDR0000467994
NCT ID:
NCT00321633
Start Date:
September 2005
Completion Date:
Related Keywords:
- brca1 Mutation Carrier
- brca2 Mutation Carrier
- Breast Cancer
- Hereditary Breast/Ovarian Cancer (brca1, brca2)
- stage IV breast cancer
- recurrent breast cancer
- hereditary breast/ovarian cancer (BRCA1, BRCA2)
- BRCA1 mutation carrier
- BRCA2 mutation carrier
- Breast Neoplasms
- Ovarian Neoplasms
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