Disease-free Survival
| Group | Value (percentage of participants) |
|---|---|
| T+OFS | 87.3 |
| E+OFS | 91.1 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name TEXT
United States, Australia, Belgium, Brazil, Canada, Egypt, Germany, Hungary, India, Italy, New Zealand, Peru, Slovenia, South Africa, Sweden, Switzerland, United Kingdom
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.
Active comparator
T+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Experimental
E+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
Outcomes the sponsor listed as primary.
Disease-free Survival
Time frame · 5-year estimate reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.
Breast Cancer-free Interval
Time frame · 5-year estimate reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Distant Recurrence-free Interval
Time frame · 5-year estimates reported at a median follow-up of 72 months
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up
Overall Survival
Time frame · 8-year estimates, reported at a median follow-up of 9 years
Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of participants) |
|---|---|
| T+OFS | 87.3 |
| E+OFS | 91.1 |
| Group | Value (percentage of participants) |
|---|---|
| T+OFS | 88.8 |
| E+OFS | 92.8 |
| Group | Value (percentage of participants) |
|---|---|
| T+OFS | 92.0 |
| E+OFS | 93.8 |
| Group | Value (percentage of participants) |
|---|---|
| T+OFS | 93.3 |
| E+OFS | 93.4 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| T+OFSOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. | – | 484 / 1321 | 1293 / 1321 |
| E+OFSOvarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin. | – | 496 / 1317 | 1298 / 1317 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
0 studies on this page
Indexing hint: Randomized controlled trial · 2017
Regan et al. 2017Annals of oncology : official journal of the European Society for Medical Oncologycited by 52
PMID 28911092PMC5834112DOI 10.1093/annonc/mdx285PUB-28911092
Indexing hint: Randomized controlled trial · 2015
Bernhard et al. 2015The Lancet. Oncologycited by 138
PMID 26092816PMC4562429DOI 10.1016/s1470-2045(15)00049-2PUB-26092816
Indexing hint: Randomized controlled trial · 2014
Pagani et al. 2014The New England journal of medicinecited by 530
PMID 24881463PMC4175521DOI 10.1056/nejmoa1404037PUB-24881463
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated