Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR3007
Study information
Scientific title
A randomised trial to evaluate a loading dose of medroxyprogesterone acetate with two different maintenance schedules in patients with advanced breast cancer
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
Patients are randomised to one of four treatment groups:
1. Group A: Loading dose medroxyprogesterone acetate (MPA), 1 g every 6 h for eight doses, followed by low dose maintenance 500 mg MPA daily
2. Group B: Low dose maintenance, 500 mg MPA daily
3. Group C: Loading dose MPA, 1 g every 6 h for eight doses, followed by high dose maintenance, 1000 mg MPA daily
4. Group D: High dose maintenance, 1000 mg MPA daily
Intervention type
Drug
Phase
Not Applicable
Drug names
Medroxyprogesterone acetate
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically proven advanced or metastatic disease
2. Measurable or assessable disease
3. Previously treated with tamoxifen resulting in relapse or no response
4. No previous therapy with medroxyprogesterone acetate (MPA) or other progesterones
5. No anti-cancer therapy within the preceding 4 weeks, but patients who, having stopped prior therapy show evidence of disease progression during the 4th week interval between treatments may enter the trial forthwith
6. Able to tolerate 8 weeks hormonal therapy
7. No evidence of brain metastases
8. No pre-existing malignancy, except non-melanomatous skin cancer
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1998
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
-
-
-
Funders
Funder type
Not defined
Funder name
Not available
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list