Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gas chromatography / tandem mass spectometry | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Triptorelin plus tamoxifen
- description
- Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years.
- interventionNames
- Other: gas chromatography / tandem mass spectometry
- type
- EXPERIMENTAL
- label
- Triptorelin plus exemestane
- description
- Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years.
- interventionNames
- Other: gas chromatography / tandem mass spectometry
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 0 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available