Clinical trial NCT00975676: 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
Official title: A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
Lead sponsor: ETOP IBCSG Partners Foundation
Sponsor class: NETWORK
First posted: 2009-09-11
Enrollment: 123
Sex: FEMALE
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Estrogen Levels (Estradiol [E2], Estrone [E1], and Estrone Sulphate [E1S]) at Different Time Points During the First 4 Years of Treatment With Triptorelin (Trip) in Combination With Either Tamoxifen (T) or Exemestane (E), IBCSG 24-02 SOFT-EST Substudy
timeFrame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
measure: Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
timeFrame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Secondary outcomes:
measure: Comparison of Estrogen Levels at Different Time Points During Treatment
timeFrame: baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
measure: Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression
timeFrame: Four years after randomization
measure: Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
timeFrame: Baseline
measure: Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
timeFrame: Baseline
measure: Endocrine Functions (FSH and LH) Status According to Treatment Assignments
timeFrame: Less than 12 months, at 12 months
Other outcomes:
Locations:
city: Saint-Cloud
country: France
facility: Centre Rene Huguenin
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Pavia
country: Italy
facility: Salvatore Maugeri Foundation
city: Udine
country: Italy
facility: Clinica Oncologica, Policlinico Univeritario
city: Lima
country: Peru
facility: INEN (Instituto de Enfermedades Neoplasicas)
city: Lisboa
country: Portugal
facility: Centro de Lisboa
city: Barcelona
country: Spain
facility: Vall d'Hebron University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr Negrin
city: Lleida
country: Spain
facility: H.U. Arnau de Vilanova
city: Madrid
country: Spain
facility: Centro Oncologico Md Anderson
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Palma
country: Spain
facility: Hospital Son Dureta
city: Palma
country: Spain
facility: Hospital Son Llatzer
city: Reus
country: Spain
facility: Hospital Sant Joan de Reus
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital Gothenburg
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Lausanne
country: Switzerland
facility: Multidisciplinary Oncology Centre, CHUV
city: Thun
country: Switzerland
facility: Spital Thun
city: Zürich
country: Switzerland
facility: Brust-Zentrum
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Prudence Francis, MD
role: STUDY_CHAIR
References: