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Clinical Trials/EUCTR2016-004384-39-AT
EUCTR2016-004384-39-AT
Active, not recruiting
Phase 1

A prospective, open, randomized, phase II study of carboplatin/olaparib in the pre-operative treatment of patients with triple-negative primary breast cancer which exhibit the features of positive homologous recombination deficiency (HRD) status

Austrian Breast & Colorectal Cancer Study Group (ABCSG)0 sites90 target enrollmentNovember 6, 2018
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ConditionsEarly invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsLynparza

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Early invasive triple negative breast cancer with positive HRD status (acc. to Myriad mychoice© test)
Sponsor
Austrian Breast & Colorectal Cancer Study Group (ABCSG)
Enrollment
90
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 6, 2018
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Austrian Breast & Colorectal Cancer Study Group (ABCSG)

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed informed consent prior to any study specific assessments and procedures
  • •2\. Patients must be \= 18 years of age
  • •3\. Pre\-menopausal (incl. peri\-menopausal) and postmenopausal women and men with core\-biopsied, early primary triple\-negative (acc. to local standards) invasive breast cancer
  • •4\. Positive HRD status (centrally assessed) in core\-biopsy sample of the breast
  • •5\. Absence of distant metastasis (M0\) as assessed acc. to institutional standards within 90 days prior to randomization
  • •6\. Unilateral early invasive TNBC patients.
  • •7\. Willingness to undergo adequate lymph node procedures (e.g., sentinel/ axillary lymph node dissection) acc. to institutional standards
  • •8\. Patients must have normal organ and bone marrow function measured within 28 days prior to randomization as defined below:
  • •Haemoglobin (Hb) \=10\.0 g/dL
  • •Absolute neutrophil count (ANC) \=1\.5 x 109/L

Exclusion Criteria

  • •1\. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca/ABCSG staff and/or staff at the study site)
  • •2\. Previous randomization in the present study
  • •3\. Participation in another clinical study with an investigational product during the last 6 months (i.e. 183 days) prior to randomization
  • •4\. Any previous treatment with a PARP inhibitor, including olaparib
  • •5\. Prior ipsilateral invasive breast cancer and/or ipsilateral Ductal Carcinoma in Situ (DCIS) and/or prior chemotherapy for any breast cancer
  • •Patients with contralateral invasive breast cancer and/or contralateral DCIS diagnosed \=5 years prior to randomization if curatively treated without chemotherapy are eligible
  • •6\. Bilateral invasive breast cancer
  • •7\. Patients with second primary malignancy are ineligible except for the following:
  • •Adequately treated non\-metastatic, non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, stage 1 grade 1 endometrial carcinoma or
  • •Other curatively treated malignancies diagnosed \=5 years prior to randomization with no evidence of disease for at least 5 years

Outcomes

Primary Outcomes

Not specified

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