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 (SOFT-EST)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

International Breast Cancer Study Group

ClinicalTrials.gov Identifier:

NCT00975676

First received: September 10, 2009

Last updated: July 26, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2009

Last Updated Date

July 26, 2012

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]
Proportion of patients who receive exemestane experiencing suboptimal estrogen suppression [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]
Proportion of patients who receive exemestane experiencing suboptimal estrogen suppression [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00975676 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of estrogen levels at different time points during treatment [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]
Potential predictive factors of ineffective estrogen suppression [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]
Predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]
Comparison of disease-free survival of suboptimally estrogen-suppressed patients with that of patients with optimal suppression [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]
Endocrine function (FSH and LH) [ Time Frame: Four years after randomization ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Comparison of estrogen levels at different time points during treatment [ Designated as safety issue: No ]
Potential predictive factors of ineffective estrogen suppression [ Designated as safety issue: No ]
Predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression [ Designated as safety issue: No ]
Comparison of disease-free survival of suboptimally estrogen-suppressed patients with that of patients with optimal suppression [ Designated as safety issue: No ]
Endocrine function (FSH and LH) [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Other: gas chromatography / tandem mass spectometry

Determination of estrogen levels through gas chromatography.

Study Arm (s)

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

Intervention: Other: gas chromatography / tandem mass spectometry
Experimental: Triptorelin plus exemestane
Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.

Intervention: Other: gas chromatography / tandem mass spectometry

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

February 2015

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Spain

Administrative Information

NCT Number ^ICMJE

NCT00975676

Other Study ID Numbers ^ICMJE

CDR0000650841, IBCSG 24-02-SOFT-EST, SOLTI 0801, BIG 2-02

Has Data Monitoring Committee

Yes

Responsible Party

International Breast Cancer Study Group

Study Sponsor ^ICMJE

International Breast Cancer Study Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Prudence Francis, MD

Peter MacCallum Cancer Centre, Australia

Information Provided By

International Breast Cancer Study Group

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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