A Study Evaluating Megestrol Acetate Modulation in Hormone Receptor Positive Advanced Breast Cancer (MEGA)
Breast Neoplasm
About this trial
This is an interventional treatment trial for Breast Neoplasm focused on measuring Megestrol Acetate, Steroid, Receptors
Eligibility Criteria
Inclusion Criteria:
- Metastatic breast cancer with ER and/or PR positive (primary tumor)
- Metastatic site amenable to biopsy
Exclusion Criteria:
- Platelet count below 100,000 / mm3
- Renal or hepatic impairment
- Coagulation disorder
Sites / Locations
- Hospital do Cancer IIIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Megestrol acetate
Anastrozole
Letrozole
Exemestane
Tamoxifen
Fulvestrant
Megestrol acetate 160 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Anastrozole 1 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Letrozole 2.5 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Exemestane 25 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Tamoxifen 20 mg PO daily until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.
Fulvestrant 500 mg intramuscularly (IM) d1, d14, d28 and q28 days until disease progression or unacceptable toxicity Tumor biopsy and blood collection before treatment initiation and at the time of disease progression.