N/A
Completed N=123
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
Source: ClinicalTrials.gov NCT00975676 ↗Enrolled (actual)
123
Serious AEs
—
Results posted
Oct 2021
Primary outcomePrimary: 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 — 109.81; 96.55; 4.876; 3.973 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
109.81; 96.55; 4.876; 3.973; 3.761; 3.672 | — |
| PRIMARY Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression |
74; 17; 16; 12; 12; 8 | — |
| SECONDARY Comparison of Estrogen Levels at Different Time Points During Treatment |
0; 0; -70; -76; -69; -82 | — |
| SECONDARY Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression |
3; 5; 18; 57; 13; 24 | — |
| SECONDARY Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm |
80; 39; 50; 41; 928; 715 | — |
| SECONDARY Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm |
6; 32; 6; 21 | — |
| SECONDARY Endocrine Functions (FSH and LH) Status According to Treatment Assignments |
2.0; 7.0; 2.2; 6.5; 0.2; 0.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00975676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.