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)

September 27, 2021 updated by: ETOP IBCSG Partners Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Cloud, France
        • Centre René Huguenin
  • Hungary
      • Budapest, Hungary
        • National Institute of Oncology
  • Italy
      • Pavia, Italy
        • Salvatore Maugeri Foundation
      • Udine, Italy
        • Clinica Oncologica, Policlinico Univeritario
  • Peru
      • Lima, Peru
        • INEN (Instituto de Enfermedades Neoplasicas)
  • Portugal
      • Lisboa, Portugal
        • Centro de Lisboa
  • Spain
      • Barcelona, Spain
        • Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Vall D'Hebron University Hospital
      • Las Palmas de Gran Canaria, Spain
        • Hospital Dr Negrin
      • Lleida, Spain
        • H.U. Arnau de Vilanova
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain
        • Centro Oncológico MD Anderson
      • Palma, Spain
        • Hospital Son Dureta
      • Palma, Spain
        • Hospital Son Llatzer
      • Reus, Spain
        • Hospital Sant Joan de Reus
      • Tarragona, Spain
        • Hospital Sant Pau i Santa Tecla
      • Valencia, Spain
        • Instituto Valenciano de Oncologia
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska University Hospital Gothenburg
  • Switzerland
      • Chur, Switzerland
        • Kantonsspital Graubünden
      • Lausanne, Switzerland
        • Multidisciplinary Oncology Centre, CHUV
      • Thun, Switzerland
        • Spital Thun
      • Zürich, Switzerland
        • Brust-Zentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 120 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Triptorelin plus tamoxifen
Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
Other: gas chromatography / tandem mass spectometry
Determination of estrogen levels through gas chromatography.
EXPERIMENTAL: Triptorelin plus exemestane
Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
Other: gas chromatography / tandem mass spectometry
Determination of estrogen levels through gas chromatography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
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.
0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
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
Four years after randomization
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.
Baseline
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.
Baseline
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)
Less than 12 months, at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Investigators

  • Study Chair: Prudence Francis, MD, Peter MacCallum Cancer Centre, Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 25, 2008

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (ESTIMATE)

September 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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