Study of Estrogen Levels in Premenopausal Women Who Have Undergone Surgery for Breast Cancer and Are Receiving Triptorelin and Tamoxifen Citrate or Exemestane on Clinical Trial IBCSG 24-02

NCT ID: NCT00975676

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-25
• Study Completion Date: 2016-12-31

Brief Summary

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.

PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

Detailed Description

OBJECTIVES:

Primary

• Describe estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial IBCSG-2402 in premenopausal women with resected breast cancer.
• Assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane.

Secondary

• Compare estrogen levels (E2, E1, E1S) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane.
• Examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy [yes/no], type of chemotherapy received, smoking history, BMI, and evidence of menses at study entry).
• Investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period).
• Compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis).
• Examine related endocrine function (FSH and LH) to further elucidate causes of suboptimal estrogen suppression.

OUTLINE: This is a multicenter study.

Blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for measurement of estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) by gas chromatography-mass spectrometry and measurement of endocrine function (FSH and LH).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triptorelin plus tamoxifen

Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.

Group Type: EXPERIMENTAL

gas chromatography / tandem mass spectometry

Intervention Type: OTHER

Determination of estrogen levels through gas chromatography.

Triptorelin plus exemestane

Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.

Group Type: EXPERIMENTAL

gas chromatography / tandem mass spectometry

Intervention Type: OTHER

Determination of estrogen levels through gas chromatography.

Interventions

gas chromatography / tandem mass spectometry

Determination of estrogen levels through gas chromatography.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed resected breast cancer
• Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required

• Randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane
• Hormone receptor status:

• Estrogen receptor- and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Premenopausal

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ETOP IBCSG Partners Foundation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prudence Francis, MD

Role: STUDY_CHAIR

Peter MacCallum Cancer Centre, Australia

Locations

Centre Rene Huguenin

Saint-Cloud, , France

National Institute of Oncology

Budapest, , Hungary

Salvatore Maugeri Foundation

Pavia, , Italy

Clinica Oncologica, Policlinico Univeritario

Udine, , Italy

INEN (Instituto de Enfermedades Neoplasicas)

Lima, , Peru

Centro de Lisboa

Lisbon, , Portugal

Vall d'Hebron University Hospital

Barcelona, , Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Hospital Dr Negrin

Las Palmas de Gran Canaria, , Spain

H.U. Arnau de Vilanova

Lleida, , Spain

Centro Oncologico Md Anderson

Madrid, , Spain

Hospital Ramon Y Cajal

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Son Dureta

Palma, , Spain

Hospital Son Llatzer

Palma, , Spain

Hospital Sant Joan de Reus

Reus, , Spain

Hospital Sant Pau i Santa Tecla

Tarragona, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Sahlgrenska University Hospital Gothenburg

Gothenburg, , Sweden

Kantonsspital Graubünden

Chur, , Switzerland

Multidisciplinary Oncology Centre, CHUV

Lausanne, , Switzerland

Spital Thun

Thun, , Switzerland

Brust-Zentrum

Zurich, , Switzerland

Countries

France; Hungary; Italy; Peru; Portugal; Spain; Sweden; Switzerland

Other Identifiers

IBCSG 24-02-SOFT-EST

Identifier Type: -

Identifier Source: secondary_id

SOLTI 0801

Identifier Type: -

Identifier Source: secondary_id

BIG 2-02

Identifier Type: -

Identifier Source: secondary_id

CDR0000650841

Identifier Type: -

Identifier Source: org_study_id