This phase II study is evaluating the effectiveness of hormone therapy (letrozole) when combined with targeted therapy (alpelisib or ribociclib) in post-menopausal women with advanced gynaecological cancers that are hormone-receptor positive.
This trial is treating patients with hormone-receptor positive endometrial cancer, endometrial stromal sarcoma, leiomyosarcoma, granulosa cell tumours, low grade epithelial cancer of the ovary, platinum resistant high-grade epithelial cancers of the ovary, fallopian tube and peritoneum,, and other gynaecological cancers.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment, but your cancer has come back.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
The activity and tolerability of Aromatase inhibitor plus PI3KCA inhibitor or CDK4/6 inhibitor in women with hormone receptor positive recurrent/metastatic gynaecological neoplasms (PARAGON-II)
Cooperative Group
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Other Non-Commercial Sponsor
University of Sydney
Summary
Eligible participants will be allocated to one of two treatment groups based on their PIK3CA mutation status. Participants in the PIK3CA mutation group will receive letrozole (2.5mg) oral tablets once daily continuously, plus alpelisib (300mg) oral tablet once daily continuously until disease progression or intolerance. Participants in the PIK3CA non-mutated wild-type/unknown group will receive letrozole (2.5mg) oral tablet once daily continuously, plus ribociclib (600mg) oral capsule once daily with a 3-week on/1-week off schedule until disease progression or intolerance. Oral letrozole will continue during the 1 week off ribociclib treatment.
Recruiting Hospitals Read More