Trial Outcomes & Findings for Extended Endocrine Therapy for Premenopausal Women With Breast Cancer (NCT NCT00903162)

Last Updated: 2016-04-18

Results Overview

The tolerability at one year of ovarian function suppression (OFS) using leuprolide and letrozole in this patient population. Specifically, the number of patients who discontinued treatment prior to one year due to toxicity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

1 year

Results posted on

2016-04-18

Participant Flow

Potential patients were approached in the Dana-Farber Breast Oncology clinic and Newton Wellesley Hospital. Eligible patients were then presented with the study and given an opportunity to sign consent. The recruitment period ran from March 30th 2009 to May 1st, 2012.

A total of 17 patients were enrolled in this study; however, only 16 patients started treatment. One patient withdrew from the study before starting treatment.

Participant milestones

Participant milestones
Measure	Letrozole-Leuprolide Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally. leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)
Overall Study STARTED	16
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Letrozole-Leuprolide n=17 Participants Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally. leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45.1 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Between September 15, 2009, and January 18, 2013, 17 patients were enrolled, but only 16 actually began protocol-directed treatment. Of the 16, 4 stopped treatment before completing even 1 year of protocol-directed therapy, owing to toxicity.

Outcome measures

Outcome measures
Measure	Letrozole-Leuprolide n=16 Participants Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally. leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)
Tolerability at One Year of Ovarian Function Suppression (OFS) Using Leuprolide and Letrozole.	4 participants

SECONDARY outcome

Timeframe: 2 years

Population: This data was not collected nor analyzed because of too few participants to be meaningful.

Ovarian function suppression (OFS) combined with aromatase inhibition combined with intravenous bisphosphonate therapy on bone mineral density in this patient population.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: This data was not collected nor analyzed because of too few participants to be meaningful.

OFS combined with aromatase inhibitor therapy on the incidence and severity of menopausal symptoms, sexual dysfunction, musculoskeletal complaints, other side effects and overall quality of life in this population.

Outcome measures

Outcome data not reported

Adverse Events

Letrozole-Leuprolide

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Letrozole-Leuprolide n=17 participants at risk Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally. leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)
Endocrine disorders Hot Flashes	70.6% 12/17 • Number of events 12 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Reproductive system and breast disorders Vaginal Dryness	64.7% 11/17 • Number of events 11 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Nervous system disorders Headache	35.3% 6/17 • Number of events 6 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Musculoskeletal and connective tissue disorders Myalgia	70.6% 12/17 • Number of events 12 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
General disorders Flu-like Symptoms, Fever, or Rigors	11.8% 2/17 • Number of events 2 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Gastrointestinal disorders Nausea	17.6% 3/17 • Number of events 3 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Psychiatric disorders Insomnia	17.6% 3/17 • Number of events 3 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
General disorders Fatigue	35.3% 6/17 • Number of events 6 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Reproductive system and breast disorders Sexual Dysfunction	23.5% 4/17 • Number of events 4 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
General disorders Injection Site Reaction or Rash	17.6% 3/17 • Number of events 3 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.
Reproductive system and breast disorders Vaginal Discharge	11.8% 2/17 • Number of events 2 • Adverse events data were collected for the two years that patients were on study treatments. Adverse events data were collected from all participants enrolled in the study.

Additional Information

Ann Partridge, MD, MPH

Dana-Farber Cancer Institute

Phone: 617.632.3800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place