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

Breast Cancer Clinical Trial

— SOFT-EST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975676
• Other study ID #: CDR0000650841
• Secondary ID: IBCSG 24-02-SOFT
• Status: Completed
• Phase: N/A
• Start date: November 25, 2008
• Est. completion date: December 2016

Study information

• Verified date: September 2021
• Source: International Breast Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• gas chromatography / tandem mass spectometry
Determination of estrogen levels through gas chromatography.

Locations

Country	Name	City	State
France	Centre Rene Huguenin	Saint-Cloud
Hungary	National Institute of Oncology	Budapest
Italy	Salvatore Maugeri Foundation	Pavia
Italy	Clinica Oncologica, Policlinico Univeritario	Udine
Peru	INEN (Instituto de Enfermedades Neoplasicas)	Lima
Portugal	Centro de Lisboa	Lisboa
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Vall d'Hebron University Hospital	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
Sweden	Sahlgrenska University Hospital Gothenburg	Göteborg
Switzerland	Kantonsspital Graubünden	Chur
Switzerland	Multidisciplinary Oncology Centre, CHUV	Lausanne
Switzerland	Spital Thun	Thun
Switzerland	Brust-Zentrum	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
International Breast Cancer Study Group

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estrogen levels (estradiol [E2], estrone [E1], and estrone sulphate [E1S]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.	0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Primary	Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression	Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.	0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Secondary	Comparison of Estrogen Levels at Different Time Points During Treatment	Percent (%) change of estrogen levels estradiol (E2), estrone (E1), and estrone sulphate (E1S) at each timepoint from baseline: e.g. {E2(t)-E2(0)} / E2(0)*100, where t= 3, 6, 12, 18, 24, 36, and 48 months from randomization	baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
Secondary	Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression	Potential predictive factors of ineffective estrogen suppression (SES) (with E2 > 2.72 pg/mL, or any vaginal bleeding > 3 months after triptorelin start or pregnancy) such as: age, evidence of menses at entry, BMI, chemotherapy (yes/no), and, type of chemotherapy received	Four years after randomization
Secondary	Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm	The secondary analysis explored baseline estrogen levels (E2, E1, E1S) with suboptimal estrogen suppression (SES) where estrogen (E2) > 2.72 pg/mL in the exemestane + triptorelin arm.	Baseline
Secondary	Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm	The secondary analysis explored endocrine functions (FSH, LH) with suboptimal estrogen suppression (SES) where estrogen (E2) > 2.72 pg/mL in the exemestane + triptorelin arm.	Baseline
Secondary	Endocrine Functions (FSH and LH) Status According to Treatment Assignments	Endocrine function (FSH, LH) status according to treatment assignments at 12 months using 12 month data alone or 12 month data plus earlier data (when 12 month not available)	Less than 12 months, at 12 months