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Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

Primary Purpose

brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
carboplatin
docetaxel
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for brca1 Mutation Carrier focused on measuring stage IV breast cancer, recurrent breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), BRCA1 mutation carrier, BRCA2 mutation carrier

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Melbourne Hospital
  • Soroka University Medical Center
  • Naharia Hospital
  • Chaim Sheba Medical Center
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
  • Vall d'Hebron University Hospital
  • Lund University Hospital
  • Addenbrooke's Hospital
  • Royal Devon and Exeter Hospital
  • UCL Cancer Institute
  • Cookridge Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Guy's Hospital
  • Royal Marsden - Surrey
  • Christie Hospital
  • Clatterbridge Centre for Oncology
  • James Paget Hospital
  • Mount Vernon Cancer Centre at Mount Vernon Hospital
  • Norfolk and Norwich University Hospital
  • Dorset Cancer Centre
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Southampton General Hospital
  • Torbay Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Velindre Cancer Center at Velindre Hospital

Outcomes

Primary Outcome Measures

Response and toxicity

Secondary Outcome Measures

Time to progression

Full Information

First Posted
May 2, 2006
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00321633
Brief Title
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
Official Title
A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University College London Hospitals

4. Oversight

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
Keywords
stage IV breast cancer, recurrent breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), BRCA1 mutation carrier, BRCA2 mutation carrier

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Response and toxicity
Secondary Outcome Measure Information:
Title
Time to progression

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP
Organizational Affiliation
Guy's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Naharia Hospital
City
Naharia
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
City
Lisbon
ZIP/Postal Code
1099-023 Codex
Country
Portugal
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
SE-22185
Country
Sweden
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Cookridge Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden - Surrey
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Paget Hospital
City
Norfolk
State/Province
England
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

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