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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: gas chromatography / tandem mass spectometry
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: November 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00975676

Locations
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Study Chair: Prudence Francis, MD Peter MacCallum Cancer Centre, Australia
  More Information

Additional Information:
No publications provided

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00975676     History of Changes
Other Study ID Numbers: CDR0000650841, IBCSG 24-02-SOFT-EST, SOLTI 0801, BIG 2-02
Study First Received: September 10, 2009
Last Updated: November 1, 2013
Health Authority: United States: Federal Government
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Hungary: National Institute of Pharmacy

Keywords provided by International Breast Cancer Study Group:
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estrogens
Exemestane
Tamoxifen
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Bone Density Conservation Agents
Contraceptive Agents
Contraceptive Agents, Female
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014