Trial Outcomes & Findings for Premenopausal Endocrine Responsive Chemotherapy Trial (NCT NCT00066807)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

29 participants

Primary outcome timeframe

For first time at a median follow up approximately 5 years

Results posted on

2016-10-28

Participant Flow

Enrollment opened 4Aug03; the first patient was randomized on 1Jun04. The accrual goal for the study was 1750 patients. A total of 29 patients were randomized as of 31Dec06 when the trial was terminated. 25 of these 29 patients were also enrolled in the TEXT trial (IBCSG 25-02).

Participant milestones

Participant milestones
Measure	OFS Plus T or E for 5 Years Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	Chemotherapy Plus OFS Plus T or E for 5 Years Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Overall Study STARTED	14	15
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	OFS Plus T or E for 5 Years Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	Chemotherapy Plus OFS Plus T or E for 5 Years Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Overall Study Study was terminated early	14	15

Baseline Characteristics

Premenopausal Endocrine Responsive Chemotherapy Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OFS Plus T or E for 5 Years n=14 Participants Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	Chemotherapy Plus OFS Plus T or E for 5 Years n=15 Participants Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	Total n=29 Participants Total of all reporting groups
Age, Continuous	45 years n=5 Participants	45 years n=7 Participants	45 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: For first time at a median follow up approximately 5 years

Population: The trial was terminated early due to poor accrual. No outcome measure data is available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For first time at a median follow up approximately 5 years

Population: The trial was terminated early due to poor accrual. No outcome measure data is available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For first time at a median follow up approximately 5 years

Population: The trial was terminated early due to poor accrual. No outcome measure data is available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: For first time at a median follow up approximately 5 years

Population: The trial was terminated early due to poor accrual. No outcome measure data is available.

Outcome measures

Outcome data not reported

Adverse Events

OFS Plus T or E for 5 Years

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chemotherapy Plus OFS Plus T or E for 5 Years

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OFS Plus T or E for 5 Years n=14 participants at risk Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.	Chemotherapy Plus OFS Plus T or E for 5 Years n=15 participants at risk Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
Blood and lymphatic system disorders Leukopenia	0.00% 0/14 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.	20.0% 3/15 • Number of events 3 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.
Gastrointestinal disorders Vomiting	0.00% 0/14 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.	6.7% 1/15 • Number of events 1 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.
Gastrointestinal disorders Nausea	0.00% 0/14 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.	6.7% 1/15 • Number of events 1 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/14 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.	6.7% 1/15 • Number of events 1 • 5-year protocol treatment period CAVEAT: Trial was terminated early; data available ONLY for selected Grade 3-5 adverse events for chemotherapy arm. Systematic assessment included form with specific AEs related to chemotherapy. 25 out of 29 patients were co-enrolled in TEXT (IBCSG 25-02) and AEs associated with endocrine therapy are reported as part of that trial.

Other adverse events

Adverse event data not reported

Additional Information

Rudolf Maibach, Executive Officer for International Trial Activities

IBCSG

Phone: +41 31 389 91 96

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place