NCT00321633

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2

Geographic Reach
6 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Last Updated

August 26, 2013

Status Verified

July 1, 2009

Enrollment Period

4 years

First QC Date

May 2, 2006

Last Update Submit

August 23, 2013

Conditions

brca1 Mutation Carrierbrca2 Mutation CarrierBreast CancerHereditary Breast/Ovarian Cancer (brca1, brca2)

Keywords

stage IV breast cancerrecurrent breast cancerhereditary breast/ovarian cancer (BRCA1, BRCA2)BRCA1 mutation carrierBRCA2 mutation carrier

Outcome Measures

Primary Outcomes (1)

  • Response and toxicity

Secondary Outcomes (1)

  • Time to progression

Interventions

carboplatinDRUG
docetaxelDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (25)

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Naharia Hospital

Nahariya, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

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

Lisbon, 1099-023 Codex, Portugal

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Lund University Hospital

Lund, SE-22185, Sweden

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

UCL Cancer Institute

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Cookridge Hospital

Leeds, England, LS16 6QB, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

Royal Marsden - Surrey

London, England, SW3 6JJ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Paget Hospital

Norfolk, England, NR31 6LA, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsHereditary Breast and Ovarian Cancer Syndrome

Interventions

CarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

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

    Guy's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2006

First Posted

May 4, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2009

Last Updated

August 26, 2013

Record last verified: 2009-07

Locations

AU(1)IL(3)ES(1)SE(1)PT(1)GB(18)