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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)

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ClinicalTrials.gov Identifier: NCT00975676
Recruitment Status : Completed
First Posted : September 11, 2009
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Other: gas chromatography / tandem mass spectometry Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2008
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. 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 ]
  2. Proportion of patients who receive exemestane experiencing suboptimal estrogen suppression [ Time Frame: Four years after randomization ]

Secondary Outcome Measures :
  1. Comparison of estrogen levels at different time points during treatment [ Time Frame: Four years after randomization ]
  2. Potential predictive factors of ineffective estrogen suppression [ Time Frame: Four years after randomization ]
  3. 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 ]
  4. Comparison of disease-free survival of suboptimally estrogen-suppressed patients with that of patients with optimal suppression [ Time Frame: Four years after randomization ]
  5. Endocrine function (FSH and LH) [ Time Frame: Four years after randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975676


Locations
Show Show 24 study locations
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
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Study Chair: Prudence Francis, MD Peter MacCallum Cancer Centre, Australia
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Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00975676    
Other Study ID Numbers: CDR0000650841
IBCSG 24-02-SOFT-EST
SOLTI 0801
BIG 2-02
First Posted: September 11, 2009    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases