An interventional study of gas chromatography / tandem mass spectometry in Breast Cancer, sponsored by ETOP IBCSG Partners Foundation. Completed at 24 sites in 8 countries. Open to female participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by ETOP IBCSG Partners Foundation · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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).
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 123 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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DISEASE CHARACTERISTICS:
Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 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.
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
Estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.
Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Number of Patients Who Receive Exemestane Experiencing Suboptimal Estrogen Suppression
Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.
Time frame: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization
Comparison of Estrogen Levels at Different Time Points During Treatment
Percent (%) change of estrogen levels estradiol (E2), estrone (E1), and estrone sulphate (E1S) at each timepoint from baseline: e.g. {E2(t)-E2(0)} / E2(0)\*100, where t= 3, 6, 12, 18, 24, 36, and 48 months from randomization
Time frame: baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization
Number of Participants With Potential Predictive Factors of Ineffective Estrogen Suppression
Potential predictive factors of ineffective estrogen suppression (SES) (with E2 \> 2.72 pg/mL, or any vaginal bleeding \> 3 months after triptorelin start or pregnancy) such as: age, evidence of menses at entry, BMI, chemotherapy (yes/no), and, type of chemotherapy received
Time frame: Four years after randomization
Baseline Estrogen Levels (E2, E1, E1S) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
The secondary analysis explored baseline estrogen levels (E2, E1, E1S) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Time frame: Baseline
Baseline Endocrine Function Levels (FSH, LH) With Suboptimal Estrogen Suppression (SES) in the Exemestane + Triptorelin Arm
The secondary analysis explored endocrine functions (FSH, LH) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
Time frame: Baseline
Endocrine Functions (FSH and LH) Status According to Treatment Assignments
Endocrine function (FSH, LH) status according to treatment assignments at 12 months using 12 month data alone or 12 month data plus earlier data (when 12 month not available)
Time frame: Less than 12 months, at 12 months
The SOFT-EST substudy was activated on 25 Nov 2008. Participating Centers were expected to enroll all or most patients who planned to use triptorelin as method of OFS, if randomized to receive OFS, into this substudy. The accrual goal for the substudy was 120 patients (30 T+OFS; 90 E+OFS). Enrollment of 30 patients randomly assigned to T+OFS was reached by 31 Dec 2009; enrollment of patients randomly assigned to E+OFS continued until SOFT and SOFT-EST enrollment closed on 31 Jan 2011.
| Milestone | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane |
|---|---|---|
| Started | 32 | 91 |
| Completed | 26 | 83 |
| Not completed | 6 | 8 |
| Withdrew: Baseline samples only, no sample analyzed or only single sample available | 6 | 8 |
Estrogen levels (estradiol \[E2\], estrone \[E1\], and estrone sulphate \[E1S\]) were measured at the following time points for the SOFT-EST: 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization. Some of these samples were not used, including un-scheduled sample, post surgery or vaginal bleeding, samples taken post early discontinuation (ED) or discontinuation of GnRH injections.
| pg/mL | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane |
|---|---|---|
| Estradiol (E2) levels at baseline (0 months) | 109.81 ± 119.151 | 96.55 ± 151.235 |
| Estradiol (E2) levels at 3 months | 4.876 ± 7.123 | 3.973 ± 8.439 |
| Estradiol (E2) levels at 6 months | 3.761 ± 2.02 | 3.672 ± 8.006 |
| Estradiol (E2) levels at 12 months | 4.013 ± 2.765 | 2.486 ± 5 |
| Estradiol (E2) levels at 18 months | 7.306 ± 16.325 | 2.527 ± 6.204 |
| Estradiol (E2) levels at 24 months | 4.453 ± 3.347 | 2.52 ± 6.566 |
| Estradiol (E2) levels at 36 months | 3.704 ± 2.138 | 1.654 ± 2.764 |
| Estradiol (E2) levels at 48 months | 5.914 ± 8.959 | 9.073 ± 57.307 |
| Estrone (E1) levels at baseline (0 months) | 60.27 ± 52.4 | 65.42 ± 78.12 |
| Estrone (E1) levels at 3 months | 17.8 ± 6.73 | 2.93 ± 3.33 |
| Estrone (E1) levels at 6 months | 18.66 ± 7.54 | 2.73 ± 3.12 |
| Estrone (E1) levels at 12 months | 19.05 ± 8.4 | 3.71 ± 6.35 |
| Estrone (E1) levels at 18 months | 18.64 ± 9.35 | 8.47 ± 33.42 |
| Estrone (E1) levels at 24 months | 18.96 ± 7.63 | 4.69 ± 9.16 |
| Estrone (E1) levels at 36 months | 19.49 ± 7.32 | 4.93 ± 9.16 |
| Estrone (E1) levels at 48 months | 19.14 ± 7.24 | 8.53 ± 35.07 |
| Estrone sulfate (E1S) levels at baseline (0 months) | 1437 ± 1825.06 | 1371 ± 1763.84 |
| Estrone sulfate (E1S) levels at 3 months | 281.4 ± 183.44 | 56.02 ± 133.71 |
| Estrone sulfate (E1S) levels at 6 months | 259 ± 167.23 | 54.7 ± 97.66 |
| Estrone sulfate (E1S) levels at 12 months | 278.5 ± 236.38 | 47.31 ± 130.45 |
| Estrone sulfate (E1S) levels at 18 months | 281.8 ± 160.6 | 63.52 ± 175.19 |
| Estrone sulfate (E1S) levels at 24 months | 242.6 ± 96.75 | 73.56 ± 258.29 |
| Estrone sulfate (E1S) levels at 36 months | 249.4 ± 113.27 | 53.27 ± 151.03 |
| Estrone sulfate (E1S) levels at 48 months | 231.1 ± 93.46 | 112 ± 556.81 |
Suboptimal estrogen suppression (SES), estradiol (E2) levels greater than 2.72 pg/mL in at least 2 post-baseline samples.
| Participants | Triptorelin Plus Exemestane |
|---|---|
| Patients with E2 > 2.72 pg/mL at baseline (0 months) | 74 |
| Patients with E2 > 2.72 pg/mL at 3 months | 17 |
| Patients with E2 > 2.72 pg/mL at 6 months | 16 |
| Patients with E2 > 2.72 pg/mL at 12 months | 12 |
| Patients with E2 > 2.72 pg/mL at 18 months | 12 |
| Patients with E2 > 2.72 pg/mL at 24 months | 8 |
| Patients with E2 > 2.72 pg/mL at 36 months | 8 |
| Patients with E2 > 2.72 pg/mL at 48 months | 3 |
Percent (%) change of estrogen levels estradiol (E2), estrone (E1), and estrone sulphate (E1S) at each timepoint from baseline: e.g. {E2(t)-E2(0)} / E2(0)\*100, where t= 3, 6, 12, 18, 24, 36, and 48 months from randomization
| percent change of estrogen levels | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane |
|---|---|---|
| Percent change from baseline of estradiol (E2) at 0 months (baseline) | 0 ± 0 | 0 ± 0 |
| Percent change from baseline of estradiol (E2) at 3 months | -70 ± 40 | -76 ± 75 |
| Percent change from baseline of estradiol (E2) at 6 months | -69 ± 44 | -82 ± 62 |
| Percent change from baseline of estradiol (E2) at 12 months | -57 ± 61 | -83 ± 47 |
| Percent change from baseline of estradiol (E2) at 18 months | -61 ± 50 | -85 ± 37 |
| Percent change from baseline of estradiol (E2) at 24 months | -63 ± 48 | -79 ± 61 |
| Percent change from baseline of estradiol (E2) at 36 months | -56 ± 44 | -86 ± 33 |
| Percent change from baseline of estradiol (E2) at 48 months | -65 ± 41 | -79 ± 87 |
| Percent change from baseline of estrone (E1) at 0 months (baseline) | 0 ± 0 | 0 ± 0 |
| Percent change from baseline of estrone (E1) at 3 months | -48 ± 41 | -90 ± 18 |
| Percent change from baseline of estrone (E1) at 6 months | -43 ± 50 | -90 ± 19 |
| Percent change from baseline of estrone (E1) at 12 months | -38 ± 55 | -81 ± 61 |
| Percent change from baseline of estrone (E1) at 18 months | -44 ± 37 | -75 ± 86 |
| Percent change from baseline of estrone (E1) at 24 months | -40 ± 43 | -84 ± 33 |
| Percent change from baseline of estrone (E1) at 36 months | -29 ± 39 | -82 ± 35 |
| Percent change from baseline of estrone (E1) at 48 months | -41 ± 33 | -70 ± 133 |
| Percent change from baseline of estrone sulfate (E1S) at 0 months (baseline) | 0 ± 0 | 0 ± 0 |
| Percent change from baseline of estrone sulfate (E1S) at 3 months | -43 ± 73 | -90 ± 27 |
| Percent change from baseline of estrone sulfate (E1S) at 6 months | -50 ± 59 | -87 ± 35 |
| Percent change from baseline of estrone sulfate (E1S) at 12 months | -35 ± 82 | -92 ± 17 |
| Percent change from baseline of estrone sulfate (E1S) at 18 months | -35 ± 68 | -92 ± 16 |
| Percent change from baseline of estrone sulfate (E1S) at 24 months | -27 ± 87 | -88 ± 33 |
| Percent change from baseline of estrone sulfate (E1S) at 36 months | -26 ± 63 | -70 ± 173 |
| Percent change from baseline of estrone sulfate (E1S) at 48 months | -36 ± 66 | -87 ± 53 |
Potential predictive factors of ineffective estrogen suppression (SES) (with E2 \> 2.72 pg/mL, or any vaginal bleeding \> 3 months after triptorelin start or pregnancy) such as: age, evidence of menses at entry, BMI, chemotherapy (yes/no), and, type of chemotherapy received
| Participants | Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (E2>2.72 pg/mL) | Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (E2>2.72 pg/mL) |
|---|---|---|
| Age at randomization (years), <35 | 3 | 5 |
| Age at randomization (years), >=35 | 18 | 57 |
| Menstrual status, normal | 13 | 24 |
| Menstrual status, irregular | 3 | 11 |
| Menstrual status, persistent amenorrhea | 5 | 27 |
| BMI (kg/m2), normal (<25) | 9 | 36 |
| BMI (kg/m2), over weight (25-<30) | 8 | 16 |
| BMI (kg/m2), obese (>=30) | 3 | 9 |
| Prior chemo, no | 12 | 25 |
| Prior chemo, yes | 9 | 37 |
| Prior chemo regimen, no chemo | 12 | 25 |
| Prior chemo regimen, anthracycline-based | 3 | 7 |
| Prior chemo regimen, taxane-based | 0 | 2 |
| Prior chemo regimen, anthracycline+taxane | 6 | 28 |
The secondary analysis explored baseline estrogen levels (E2, E1, E1S) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
| pg/mL | Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL | Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL |
|---|---|---|
| Baseline estradiol (E2) | 80 (60 to 121) | 39 (6 to 83) |
| Baseline estrone (E1) | 50 (26 to 59) | 41 (23 to 71) |
| Baseline estrone sulphate (E1S) | 928 (572 to 1168) | 715 (302 to 1330) |
The secondary analysis explored endocrine functions (FSH, LH) with suboptimal estrogen suppression (SES) where estrogen (E2) \> 2.72 pg/mL in the exemestane + triptorelin arm.
| IU/L | Triptorelin Plus Exemestane With Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL | Triptorelin Plus Exemestane Without Suboptimal Estrogen Suppression (SES) With E2>2.72 pg/mL |
|---|---|---|
| Baseline follicle-stimulating hormone (FSH) | 6 (5 to 8) | 32 (10 to 58) |
| Baseline luteinizing hormone (LH) | 6 (4 to 8) | 21 (7 to 32) |
Endocrine function (FSH, LH) status according to treatment assignments at 12 months using 12 month data alone or 12 month data plus earlier data (when 12 month not available)
| IU/L | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane |
|---|---|---|
| Follicle-stimulating hormone (FSH) at 12 months | 2.0 (1.5 to 2.6) | 7.0 (5.2 to 8.8) |
| Follicle-stimulating hormone (FSH) at <=12 months | 2.2 (1.6 to 3.1) | 6.5 (4.8 to 8.7) |
| Luteinizing hormone (LH) at 12 months | 0.2 (0.1 to 0.4) | 0.1 (0.1 to 0.1) |
| Luteinizing hormone (LH) at <=12 months | 0.2 (0.1 to 0.4) | 0.1 (0.1 to 0.2) |
Collected over Four years after randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Triptorelin Plus Tamoxifen | — | — | — |
| Triptorelin Plus Exemestane | — | — | — |
Intent to treat (ITT) population: all patients receiving triptorelin plus either tamoxifen (T+Trip) or exemestane (E+Trip) with the exception of patients who withdrew consent and/or never started triptorelin. Analysis cohort (N=109): all patients from ITT population, who had two sample data were included, given the primary aims of this analysis is for the long term (4 years) data, patients with only baseline data were excluded. Fourteen patients were excluded.
| Age, Customized(Participants) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| <35 | 0 | 8 | 8 |
| 35-39 | 5 | 10 | 15 |
| 40-44 | 7 | 26 | 33 |
| 45-49 | 14 | 39 | 53 |
| Sex: Female, Male(Participants) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Female | 26 | 83 | 109 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 25 | 81 | 106 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Estradiol (E2), pg/mL(pg/mL) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Mean | 109.81 ± 119.81 | 96.55 ± 151.23 | 99.78 ± 143.68 |
| Estrone (E1), pg/mL(pg/mL) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Mean | 60.27 ± 52.40 | 65.42 ± 78.12 | 64.17 ± 72.52 |
| Estrone sulfate (E1S), pg/mL(pg/mL) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Mean | 1437.02 ± 1825.06 | 1371.21 ± 1763.84 | 1387.20 ± 1770.42 |
| Follicle-stimulating hormone (FSH), LU/L(LU/L) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Mean | 25.14 ± 29.05 | 30.30 ± 27.37 | 29.05 ± 27.73 |
| Luteinizing hormone (LH), LU/L(LU/L) | Triptorelin Plus Tamoxifen | Triptorelin Plus Exemestane | Total |
|---|---|---|---|
| Mean | 16.77 ± 16.29 | 18.97 ± 16.12 | 18.44 ± 16.11 |
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ETOP IBCSG Partners Foundation