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: November 1, 2013
Last verified: November 2013

September 10, 2009
November 1, 2013
November 2008
February 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00975676 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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
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

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.

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).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Other: gas chromatography / tandem mass spectometry
Determination of estrogen levels through gas chromatography.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Spain
 
NCT00975676
CDR0000650841, IBCSG 24-02-SOFT-EST, SOLTI 0801, BIG 2-02
Yes
International Breast Cancer Study Group
International Breast Cancer Study Group
Not Provided
Study Chair: Prudence Francis, MD Peter MacCallum Cancer Centre, Australia
International Breast Cancer Study Group
November 2013

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