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Completed

NCT Number: 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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

0 year–120 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Rene Huguenin, Saint-Cloud, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gas chromatography / tandem mass spectometry

Other

Determination of estrogen levels through gas chromatography.

Primary outcomes

  1. 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

    Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

    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.

  2. Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression

    Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

    Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.

Secondary outcomes

  1. Comparison of Estrogen Levels at Different Time Points During Treatment

    Time frame: baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization

    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

  2. Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression

    Time frame: Four years after randomization

    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

  3. Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm

    Time frame: Baseline

    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.

  4. Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm

    Time frame: Baseline

    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.

  5. Endocrine Functions (FSH and LH) Status According to Treatment Assignments

    Time frame: Less than 12 months, at 12 months

    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)

Sponsors and collaborators

Lead sponsor

ETOP IBCSG Partners Foundation

Network

Registry information

Official study 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

Acronym: SOFT-EST

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2009
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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