Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321633
• Other study ID #: CDR0000467994
• Secondary ID: CRUK-BRCA-TRIALE
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2006
• Last updated: August 23, 2013
• Start date: September 2005

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• carboplatin

• docetaxel

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville	Victoria
Israel	Soroka University Medical Center	Beer-Sheva
Israel	Naharia Hospital	Naharia
Israel	Chaim Sheba Medical Center	Tel Hashomer
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA	Lisbon
Spain	Vall d'Hebron University Hospital	Barcelona
Sweden	Lund University Hospital	Lund
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	UCL Cancer Institute	Hampstead, London	England
United Kingdom	Cookridge Hospital	Leeds	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Royal Marsden - Surrey	London	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	James Paget Hospital	Norfolk	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Torbay Hospital	Torquay	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Countries where clinical trial is conducted

Australia,  Israel,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response and toxicity			Yes
Secondary	Time to progression			No