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Published on: December 5, 2020
Assessment of Ovarian Function in Phase III (Neo)Adjuvant Breast Cancer Clinical Trials: A Systematic Evaluation
Wanyuan Cui1,2, Prudence A Francis1,2, Sherene Loi2,3
1Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
Background:
Loss of ovarian function is a recognized adverse effect of chemotherapy for breast cancer and of great importance to patients. Little is known about the ovarian toxicity of newer cancer treatments. This study examined whether breast cancer clinical trials include assessment of the impact of trial interventions on ovarian function.
Methods:
Eligible trials were phase III (neo)adjuvant trials of pharmacologic treatments for breast cancer, recruiting between June 2008 and October 2019, which included premenopausal women. MEDLINE, EMBASE, Clinicaltrials.gov, and EudraCT were searched. Data were extracted from trial publications, protocols, databases, and a survey sent to all trial chairs. Tests of statistical significance were 2-sided.
Results:
Of 2354 records identified, 141 trials were eligible. Investigational treatments included chemotherapy (36.9%), HER2 targeted (24.8%), endocrine (12.8%), immunotherapy (7.8%), cyclin-dependent kinase 4/6 inhibitors (5.0%), and poly-ADP-ribose polymerase inhibitors (2.8%). Ovarian function was a prespecified endpoint in 13 (9.2%) trials. Forty-five (31.9%) trials collected ovarian function data, but only 33 (23.4%) collected posttrial-intervention data. Common postintervention data collected included menstruation (15.6%), pregnancy (13.5%), estradiol (9.9%), and follicle-stimulating hormone levels (8.5%). Only 4 (2.8%) trials collected postintervention anti-müllerian hormone levels, and 3 (2.1%) trials collected antral follicle count. Of 22 trials investigating immunotherapy, cyclin-dependent kinase 4/6 inhibitors, or poly-ADP-ribose polymerase inhibitors, none specified ovarian function as an endpoint, but 4 (18.2%) collected postintervention ovarian function data.
Conclusions:
The impact of pharmacologic interventions on ovarian function is infrequently assessed in phase III breast cancer (neo)adjuvant trials that include premenopausal women. Trialists should consider inclusion of ovarian function endpoints when designing clinical trials, given its importance for informed decision making.
Insights
Ovarian function impact is rarely assessed in breast cancer trials. Future trial designs should include ovarian function endpoints for patient decision-making.
Area of Science:
- Oncology
- Reproductive Endocrinology
Background:
- Ovarian function loss is a known adverse effect of chemotherapy for breast cancer.
- The ovarian toxicity of newer breast cancer treatments is not well understood.
Purpose of the Study:
- To examine if breast cancer clinical trials assess the impact of interventions on ovarian function.
Main Methods:
- Phase III (neo)adjuvant pharmacologic breast cancer trials recruiting premenopausal women between June 2008 and October 2019 were identified.
- Data were extracted from publications, protocols, databases, and surveys sent to trial chairs.
Main Results:
- Of 141 eligible trials, only 9.2% prespecified ovarian function as an endpoint.
- 31.9% collected ovarian function data, but only 23.4% collected post-intervention data.
- Newer treatments like immunotherapy and CDK4/6 inhibitors rarely included ovarian function endpoints.
Conclusions:
- Pharmacologic interventions' impact on ovarian function is infrequently assessed in breast cancer trials.
- Including ovarian function endpoints in trial design is crucial for informed patient decisions.
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