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:
International Breast Cancer Study Group
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
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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
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: | July 26, 2012 |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogens Tamoxifen Triptorelin Exemestane Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal |
Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 22, 2013