Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01726322
Other study ID # CTRIAL-IE (ICORG) 10-16
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 2012
Est. completion date July 13, 2020

Study information

Verified date April 2023
Source Cancer Trials Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

It is proposed that levels of AMH and inhibin A and B measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition, AMH might give an indication of the possible efficacy of GNRH agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no children and a wish to have some in the future. Older women who have completed their families are less likely to be offered a GNRH agonist.


Recruitment information / eligibility

Status Terminated
Enrollment 216
Est. completion date July 13, 2020
Est. primary completion date July 13, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Locations

Country Name City State
Ireland Bon Secours Hospital Cork
Ireland Cork University Hospital Cork
Ireland Our Lady of Lourdes Hospital Drogheda Louth
Ireland Beacon Hospital Dublin Dublin 18
Ireland Beaumont Hospital Dublin
Ireland St James Hospital Dublin
Ireland St Vincent's University Hospital Dublin
Ireland Tallaght University Hospital Dublin
Ireland Sligo General Hospital Sligo
Ireland Waterford Regional Hospital Waterford

Sponsors (1)

Lead Sponsor Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer AMH levels will be taken at specified intervals until 3 years post chemotherapy
Secondary Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens up to 3 years post chemotherapy
Secondary Correlation between CIA and depletion of ovarian follicular reserve. To assess the correlation between CIA and depletion of ovarian follicular reserve. up to 3 years post chemotherapy
Secondary Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients up to 3 years post chemotherapy
Secondary Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer To determine the efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer (administration of GNRH agonists is dependent on the treating oncologist's judgment of the patient's case and prac-tices and is not to be influenced by study participation). up to 3 years post chemotherapy
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A