Clinical trial · Observational
Ovarian Reserve in Premenopausal Breast Cancer
A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Summary
Brief summary (as posted)
This is a translational, mutlicentre study. The aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Premenopausal Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
- timeFrame
- AMH levels will be taken at specified intervals until 3 years post chemotherapy
- description
- To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
Secondary outcomes (4)
- measure
- Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
- timeFrame
- up to 3 years post chemotherapy
- description
- To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
- measure
- Correlation between CIA and depletion of ovarian follicular reserve.
- timeFrame
- up to 3 years post chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Documented histological diagnosis of invasive breast cancer 2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)\* 3. Female patients aged between 18 and 50 years 4. Premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab OR The patient's last menstrual period had to be within the last 180 days OR An IUD is used for contraception. 5. Ability to provide written informed consent * Patients treated with GNRH agonist or adjuvant Herceptin or participating in other clinical trials are also eligible Exclusion Criteria: 1. Patients with hypothalamic/pituitary disorder 2. History of ovarian tumour 3. Current pregnancy
References
Publications (0)
Data not yet available