Study on Androgen Receptor and Triple Negative Breast Cancer (NCT03383679) | Clinical Trial Compass
CompletedPhase 2
Study on Androgen Receptor and Triple Negative Breast Cancer
France94 participantsStarted 2018-03-14
Plain-language summary
This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2.
The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Woman, ≥18 years old;
✓. Histologically confirmed locally recurrent (unresectable) or metastatic breast cancer;
✓. Triple negative breast cancer:
✓. Androgen receptor (AR)-positive, as defined centrally by a ≥ 10% tumor stained cells by IHC Note: AR assessment by local pathologist before inclusion is not mandatory;
✓. Patients with a relapse or progressive disease should be chemotherapy naïve or have received a maximum of one line of chemotherapy for advanced disease (providing they are not presenting with life-threatening metastasis); patients could have received adjuvant or neo-adjuvant therapy;
✓. In the exceptional situation of pre-menopausal patient, the addition of a LHRH analog is recommended (androgens might act as an estrogen antagonist in premenopausal patients);
✓. Presence of measurable or evaluable disease according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)
✓. Eastern cooperative oncology group (ECOG) ≤1;
Exclusion criteria
✕. HER2-positive status (positivity defined as IHC3+ and/or FISH amplification ≥2);
✕. Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for ≥5 years and patient is deemed to be at low risk for recurrence;
✕. Active brain metastases or leptomeningeal disease; history of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or Magnetic resonance Imaging (MRI) of the brain;
✕. Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;
✕. Significant cardiovascular disease, including any of the following:
✕. NYHA class III-IV congestive heart failure
✕. Stroke, unstable angina pectoris or myocardial infarction within the past 6 months