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Paragon (ANZGOG-0903): Phase 2 Study of Anastrozole in Women With Estrogen or Progesterone Receptor-Positive
Anthony Bonaventura1, Rachel L OʼConnell, Cristina Mapagu
1*Calvary Mater Newcastle, Newcastle; †National Health and Medical Research Council Clinical Trials Centre and ‡Westmead Institute for Medical Research, University of Sydney, Sydney; §Department of Gynaecological Oncology, Westmead Hospital, Westmead; and ∥School of Medicine, Western Sydney University; ¶Chris O'Brien Lifehouse; and #School of Medicine, University of Sydney, Sydney, New South Wales; **Royal Women's Hospital; ††University of Melbourne; ‡‡Division of Cancer Medicine, Peter MacCallum Cancer Centre; and §§Mercy Hospital for Women, Melbourne, Victoria; ∥∥Royal Brisbane and Women's Hospital and ¶¶School of Medicine, University of Queensland, Brisbane, Queensland; and ##Pathology North and ***Faculty of Health and Medicine, University of Newcastle, Newcastle; and †††Department of Medical Oncology, Prince of Wales Hospital, Sydney, New South Wales, Australia.
Background:
There is some evidence that a subset of patients with recurrent ovarian cancer may benefit from antiestrogen therapy. The Paragon study is a basket protocol that includes a series of phase 2 trials investigating the activity of anastrozole in patients with estrogen or progesterone receptor-positive recurrent gynecological cancers. We report the results of treatment in patients with platinum-resistant or -refractory recurrent epithelial ovarian cancer.
Methods:
Postmenopausal women who had estrogen and/or progesterone receptor-positive platinum-resistant or platinum-refractory recurrent ovarian cancer and disease measurable by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or GCIG (Gynecologic Cancer InterGroup) CA-125 criteria were eligible. Patients received anastrozole 1 mg daily until progression or unacceptable toxicity. The study was prospectively registered (ACTRN12610000796088).
Results:
There were 49 evaluable patients, and clinical benefit was observed in 13 (27%; 95% confidence interval [CI], 16%-40%). There were no complete or partial RECIST version 1.1 responses. Clinical benefit was associated with higher global quality-of-life scores. Median progression-free survival was 2.7 months (95% CI, 2.0-2.8 months). The median duration of clinical benefit was 2.8 months (95% CI, 2.6-5.7 months). Most patients (83%) progressed within 6 months. Seven patients continued on treatment for longer than 6 months. Anastrozole was well tolerated in most patients. Subgroup analysis suggested greater clinical benefit in patients with tumors with estrogen-receptor histoscore of more than 200, but this difference was not statistically significant.
Conclusions:
A subset of patients with estrogen- or progesterone-positive platinum-resistant or platinum-refractory recurrent epithelial ovarian cancers derives clinical benefit from anastrozole, with acceptable toxicity. The challenge remains how to identify them.
Insights
Anastrozole showed clinical benefit in a subset of patients with recurrent ovarian cancer. Identifying these patients remains a challenge for effective antiestrogen therapy.
Area of Science:
- Gynecologic Oncology
- Medical Oncology
- Pharmacology
Background:
- Recurrent ovarian cancer may respond to antiestrogen therapy in a subset of patients.
- The Paragon study investigates anastrozole in receptor-positive gynecological cancers.
- This report focuses on platinum-resistant or -refractory epithelial ovarian cancer.
Purpose of the Study:
- To investigate the efficacy of anastrozole in patients with platinum-resistant or -refractory recurrent epithelial ovarian cancer.
- To evaluate clinical benefit and toxicity of anastrozole in this patient population.
Main Methods:
- A phase 2 trial within the Paragon basket protocol.
- Inclusion of postmenopausal women with receptor-positive, platinum-resistant/refractory ovarian cancer.
- Daily anastrozole administration until disease progression or toxicity.
Main Results:
- Clinical benefit observed in 27% of 49 evaluable patients.
- No complete or partial RECIST responses; benefit linked to quality-of-life scores.
- Median progression-free survival was 2.7 months; anastrozole generally well-tolerated.
Conclusions:
- Anastrozole provides clinical benefit with acceptable toxicity in a subset of patients with specific recurrent ovarian cancers.
- Identifying patients most likely to benefit from anastrozole is crucial for treatment optimization.
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