Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether carboplatin is more effective than docetaxel in treating patients with metastatic genetic breast cancer.

PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works compared to docetaxel in treating women with metastatic genetic breast cancer.

Detailed Description

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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.

Conditions

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brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2)

Keywords

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stage IV breast cancer recurrent breast cancer hereditary breast/ovarian cancer (BRCA1, BRCA2) BRCA1 mutation carrier BRCA2 mutation carrier

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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carboplatin

Intervention Type DRUG

docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP

Role: STUDY_CHAIR

Guy's Hospital

Locations

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Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Soroka University Medical Center

Beersheba, , Israel

Site Status

Naharia Hospital

Nahariya, , Israel

Site Status

Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

Lisbon, , Portugal

Site Status

Vall d'Hebron University Hospital

Barcelona, , Spain

Site Status

Lund University Hospital

Lund, , Sweden

Site Status

Addenbrooke's Hospital

Cambridge, England, United Kingdom

Site Status

Royal Devon and Exeter Hospital

Exeter, England, United Kingdom

Site Status

UCL Cancer Institute

Hampstead, London, England, United Kingdom

Site Status

Cookridge Hospital

Leeds, England, United Kingdom

Site Status

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, United Kingdom

Site Status

Guy's Hospital

London, England, United Kingdom

Site Status

Royal Marsden - Surrey

London, England, United Kingdom

Site Status

Christie Hospital

Manchester, England, United Kingdom

Site Status

Clatterbridge Centre for Oncology

Merseyside, England, United Kingdom

Site Status

James Paget Hospital

Norfolk, England, United Kingdom

Site Status

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, England, United Kingdom

Site Status

Dorset Cancer Centre

Poole Dorset, England, United Kingdom

Site Status

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

Torbay Hospital

Torquay, England, United Kingdom

Site Status

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, United Kingdom

Site Status

Countries

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Australia Israel Portugal Spain Sweden United Kingdom