NCT02102568

Brief Summary

Prospective multicenter study, Not on Health Products that evaluates up to 2 and a half years the impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age, diagnosed with non-metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

February 14, 2024

Status Verified

August 1, 2021

Enrollment Period

6.3 years

First QC Date

March 20, 2014

Last Update Submit

February 13, 2024

Conditions

BREAST CANCER

Keywords

breast cancerChemotherapy-induced menopausequality of life

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the 2-year impact of chemo-induced menopause (CIM) on the functional score of the QLQ-C30 quality of life questionnaire in young women of childbearing age and diagnosed with breast cancer.

    Differential variation of QLQ-C30 QoL Functional Score between inclusion and at 2 years.

    3 years

Secondary Outcomes (9)

  • Evaluation of the rate of CIM after chemotherapy

    3 years

  • Sensitivity and Specificity of blood Anti-Mullerian Hormone (AMH) in the prediction of MCI

    3 years

  • Predictive value of 6-month amenorrhea on 2-year menopause

    3 years

  • Assessment of FSH (follicle stimulating hormone) and estradiol levels before chemotherapy and at the end of chemotherapy

    6 months

  • Impact of CIM on specific aspects of quality of life (anxiety, depression, body image, physical activity and quality of sleep) after breast cancer

    3 years

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

premenopausal women with age between 18 to 45 years. premenopausal women with non-metastatic breast cancer.

You may qualify if:

  • Patient aged over 18 and under 45
  • Patient without amenorrhea at diagnosis
  • Performance status less than 2 (according to WHO criteria )
  • Patient diagnosed with histologically proven non-metastatic breast cancer
  • Clinical Stages I, IIA, IIB and IIIA
  • Positive Hormone Receptors (defined by a rate of 10% of labeled cells and immunohistochemistry (IHC) ) or negative
  • Positive or negative HER2 status ( defined a score of 0 or 1 + by IHC , or a 2 + score by IHC and FISH / ISHS / CISH negative)
  • Patients to be treated with neoadjuvant or adjuvant chemotherapy
  • Satisfying hematological, renal and hepatic functions : PNN\> 2,109 / L, platelets \> 100 . 109 / L, Hb\> 10 g / dl , normal bilirubin, AST and ALT \<2.5 upper normal value ( VNS) , alkaline phosphatase \<2.5 VSN , creatinine clearance \> 60 ml / min
  • Obtaining informed consent in writing, signed and dated
  • Affiliation to Social Security system (or being the beneficiary of such a plan) under the terms of the Act of August 9, 2004

You may not qualify if:

  • Male patient
  • Metastatic cancer
  • Any T4 tumor (skin invasion, deep grip, inflammatory breast cancer)
  • Patient who underwent surgical castration of ovariectomy or hysterectomy or tubal ligation
  • Patients with endometriosis
  • Pregnant or breastfeeding patients
  • Patients with no effective contraception
  • Patients who have had hormone therapy or chemotherapy
  • Patient who have already taken Gn-RH or LH-RH analogues (chemical castration)
  • Patient whose mother was in menopause early without treatment
  • Presence of comorbidities related to fertility or medical history related to ovarian failure or sterility
  • Significant neurological or psychiatric abnormalities
  • Inability of the patient to complete the questionnaires (the language barrier)
  • Patients deprived of liberty by court or administrative decision
  • Participation in another clinical trial involving the chemical or surgical castration of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre de lutte contre le cancer - Centre Jean PERRIN

Clermont-Ferrand, 63000, France

Location

Institut Jean Godinot

Reims, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum is collected in order to measure AMH (Anti-Müllerian Hormone) levels, before the start of chemotherapy and after the end of chemotherapy treatment

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marie-Ange MOURET-REYNIER, Dr

    Centre Jean Perrin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2014

First Posted

April 3, 2014

Study Start

April 1, 2014

Primary Completion

July 10, 2020

Study Completion

December 11, 2023

Last Updated

February 14, 2024

Record last verified: 2021-08

Locations

FR(3)