CompletedPhase 2

Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

Canada99 participantsStarted 2008-07-08

Plain-language summary

This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion Criteria: * Histologically confirmed high grade serous and/or undifferentiated carcinoma of ovary, fallopian tube or peritoneum * Oestrogen, progesterone and HER2 negative advanced adenocarcinoma of the breast * Known BRCA positive breast cancer or ovarian cancer, that is not high grade serous or undifferentiated tubo-ovarian carcinoma. * Performance status of no more than 2. Exclusion Criteria: * Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry * Major surgery with 4 weeks of entering the study and must have recovered from effects of any major surgery .

What they're measuring

Objective Response Rate (ORR) Evaluated According to Response Evaluation Criteria In Solid Tumors (RECIST) Guidelines

Timeframe: Each patient with measurable disease at baseline was assessed for Objective Response from the sequence of RECIST scan data up to data cut-off, 26 March 2010. RECIST scans were performed every 8 weeks (+/- 2 weeks) from randomization.

Trial details

NCT IDNCT00679783

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03-26

Results submitted2011-07-19

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