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| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG 24-02-SOFT-EST | |||
| SOLTI 0801 | |||
| BIG 2-02 |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin plus tamoxifen | Experimental | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. |
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| Triptorelin plus exemestane | Experimental | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gas chromatography / tandem mass spectometry | Other | Determination of estrogen levels through gas chromatography. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization |
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DISEASE CHARACTERISTICS:
Histologically confirmed resected breast cancer
Concurrent enrollment on clinical trial IBCSG-2402 (SOFT trial) required
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Prudence Francis, MD | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Rene Huguenin | Saint-Cloud | France | ||||
| National Institute of Oncology |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin Plus Tamoxifen | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. The final analytic cohort included 109 patients from the intent to treat (ITT) population, who had ≥2 samples assayed or E+Trip=83, T+Trip=26 respectively, patients with only baseline data were excluded. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | 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. | 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. | 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) | Less than 12 months, at 12 months |
| Budapest |
| Hungary |
| Salvatore Maugeri Foundation | Pavia | Italy |
| Clinica Oncologica, Policlinico Univeritario | Udine | Italy |
| INEN (Instituto de Enfermedades Neoplasicas) | Lima | Peru |
| Centro de Lisboa | Lisbon | Portugal |
| Vall d'Hebron University Hospital | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Spain |
| Hospital Dr Negrin | Las Palmas de Gran Canaria | Spain |
| H.U. Arnau de Vilanova | Lleida | Spain |
| Centro Oncologico Md Anderson | Madrid | Spain |
| Hospital Ramon Y Cajal | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Son Dureta | Palma | Spain |
| Hospital Son Llatzer | Palma | Spain |
| Hospital Sant Joan de Reus | Reus | Spain |
| Hospital Sant Pau i Santa Tecla | Tarragona | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Spain |
| Instituto Valenciano de Oncologia | Valencia | Spain |
| Sahlgrenska University Hospital Gothenburg | Gothenburg | Sweden |
| Kantonsspital Graubünden | Chur | Switzerland |
| Multidisciplinary Oncology Centre, CHUV | Lausanne | Switzerland |
| Spital Thun | Thun | Switzerland |
| Brust-Zentrum | Zurich | Switzerland |
| FG001 |
| Triptorelin Plus Exemestane |
Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. The final analytic cohort included 109 patients from the intent to treat (ITT) population, who had ≥2 samples assayed or E+Trip=83, T+Trip=26 respectively, patients with only baseline data were excluded. |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triptorelin Plus Tamoxifen | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. gas chromatography / tandem mass spectometry: Determination of estrogen levels through gas chromatography. |
| BG001 | Triptorelin Plus Exemestane | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. gas chromatography / tandem mass spectometry: Determination of estrogen levels through gas chromatography. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patient characteristics for the analytic cohort of 109 patients according to treatment assignment. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Estradiol (E2), pg/mL | Excludes 2 patients without baseline samples | Mean | Standard Deviation | pg/mL |
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| Estrone (E1), pg/mL | Excludes 2 patients without baseline samples | Mean | Standard Deviation | pg/mL |
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| Estrone sulfate (E1S), pg/mL | Excludes 2 patients without baseline samples | Mean | Standard Deviation | pg/mL |
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| Follicle-stimulating hormone (FSH), LU/L | Excludes 6 patients without baseline samples | Mean | Standard Deviation | LU/L |
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| Luteinizing hormone (LH), LU/L | Excludes 5 patients without baseline samples | Mean | Standard Deviation | LU/L |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | The final (4 years) analysis cohort (N=109) consists of all patients from the intent to treat (ITT) population (N=123) who had at least 2 samples analyzed and who received at least one GnRH analogue triptorelin injection during follow-up. Fourteen patients were excluded due to the reasons of 1) never start TE and never received GnRH (gonadotropin-releasing hormone) analogue triptorelin; 2) only baseline sample available; 3) single sample at 24 months; 4) patients without sample analyzed. | Posted | Mean | Standard Deviation | pg/mL | 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization |
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| Primary | 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. | Among patients randomly assigned to exemestane + triptorelin and included in the analysis cohort (N=83), the number of patients who experienced suboptimal suppression at each timepoint, with 95% exact binomial confidence intervals (CI), were reported. Two patients were excluded due to no baseline sample. | Posted | Count of Participants | Participants | 0 (baseline), 3, 6, 12, 18, 24, 36, and 48 months after randomization |
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| Secondary | 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 | The final (4 years) analysis cohort (N=109) consists of all patients from the intent to treat (ITT) population (N=123) who had at least 2 samples analyzed and who received at least one GnRH analogue triptorelin injection during follow-up. Fourteen patients were excluded due to the reasons of 1) never start TE and never received GnRH (gonadotropin-releasing hormone) analogue triptorelin; 2) only baseline sample available; 3) single sample at 24 months; 4) patients without sample analyzed. | Posted | Mean | Standard Deviation | percent change of estrogen levels | baseline (0 months), 3, 6, 12, 18, 24, 36, and 48 months from randomization |
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| Secondary | 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 | All patients from the Intent to treat (ITT) population assigned to exemestane +triptorelin (N=83) according to suboptimal estrogen suppression (SES) with E2 > 2.72 pg/mL (suboptimal threshold) or any vaginal bleeding > 3 mos after triptorelin start or pregnancy | Posted | Count of Participants | Participants | Four years after randomization |
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| Secondary | 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. | All patients from the Intent to treat (ITT) population assigned to exemestane +triptorelin (N=83) according to suboptimal estrogen suppression (SES) with E2 > 2.72 pg/mL (suboptimal threshold) or any vaginal bleeding > 3 mos after triptorelin start or pregnancy | Posted | Median | Inter-Quartile Range | pg/mL | Baseline |
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| Secondary | 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. | All patients from the Intent to treat (ITT) population assigned to exemestane +triptorelin (N=83) according to suboptimal estrogen suppression (SES) with E2 > 2.72 pg/mL (suboptimal threshold) or any vaginal bleeding > 3 mos after triptorelin start or pregnancy | Posted | Median | Inter-Quartile Range | IU/L | Baseline |
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| Secondary | 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) | The final (4 years) analysis cohort (N=109) consists of all patients from the intent to treat (ITT) population (N=123) who had at least 2 samples analyzed and who received at least one GnRH analogue triptorelin injection during follow-up. Fourteen patients were excluded due to the reasons of 1) never start TE and never received GnRH (gonadotropin-releasing hormone) analogue triptorelin; 2) only baseline sample available; 3) single sample at 24 months; 4) patients without sample analyzed. | Posted | Median | Inter-Quartile Range | IU/L | Less than 12 months, at 12 months |
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Four years after randomization.
Adverse event data were not collected for the substudy population but were for the main study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triptorelin Plus Tamoxifen | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus tamoxifen for 5 years. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Triptorelin Plus Exemestane | Determination of estrogen levels in blood samples from patients being treated with triptorelin plus exemestane for 5 years. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Trial Activities and Deputy Director Dr. Heidi Roschitzki-Voser Organization | International Breast Cancer Study Group (IBCSG) | +41 31 511 94 00 | heidi.roschitzki@ibcsg.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D002849 | Chromatography, Gas |
| ID | Term |
|---|---|
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| 35-39 |
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| 40-44 |
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| 45-49 |
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| Estradiol (E2) levels at 3 months |
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| Estradiol (E2) levels at 6 months |
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| Estradiol (E2) levels at 12 months |
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| Estradiol (E2) levels at 18 months |
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| Estradiol (E2) levels at 24 months |
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| Estradiol (E2) levels at 36 months |
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| Estradiol (E2) levels at 48 months |
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| Estrone (E1) levels at baseline (0 months) |
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| Estrone (E1) levels at 3 months |
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| Estrone (E1) levels at 6 months |
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| Estrone (E1) levels at 12 months |
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| Estrone (E1) levels at 18 months |
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| Estrone (E1) levels at 24 months |
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| Estrone (E1) levels at 36 months |
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| Estrone (E1) levels at 48 months |
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| Estrone sulfate (E1S) levels at baseline (0 months) |
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| Estrone sulfate (E1S) levels at 3 months |
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| Estrone sulfate (E1S) levels at 6 months |
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| Estrone sulfate (E1S) levels at 12 months |
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| Estrone sulfate (E1S) levels at 18 months |
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| Estrone sulfate (E1S) levels at 24 months |
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| Estrone sulfate (E1S) levels at 36 months |
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| Estrone sulfate (E1S) levels at 48 months |
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| Units | Counts |
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| Participants |
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| Participants |
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| Participants |
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