Trial Outcomes & Findings for Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer (NCT NCT01368263)
NCT ID: NCT01368263
Last Updated: 2015-04-03
Results Overview
* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
TERMINATED
PHASE2
8 participants
1 month
2015-04-03
Participant Flow
The study opened to participant accrual on 09/13/2011 and closed to participant accrual on 05/22/2013.
Participant milestones
| Measure |
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
|
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Group 3 (E2 > 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
1
|
1
|
|
Overall Study
COMPLETED
|
6
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
n=6 Participants
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
|
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
n=1 Participants
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Group 3 (E2 > 15 pg/ml)
n=1 Participants
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
29 years
n=7 Participants
|
35 years
n=5 Participants
|
38.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 \>10% and estradiol levels of \<= 15 pg/ml at 4 weeks.
* In patients with Ki67 \>10% and \<= 15 pg/ml at 4 weeks. * The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months post neoadjuvant endocrine therapy and surgeryPopulation: None of the participants had a PEPI score and 0 and pathological stage 1.
Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 4 weeks post-treatmentPopulation: This outcome was not analyzed due to funding issues.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of definitive surgeryPopulation: 2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected
To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).
Outcome measures
| Measure |
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
n=4 Participants
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
|
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Group 3 (E2 > 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
|---|---|---|---|
|
Preoperative Endocrine Prognostic Index Score (PEPI Score)
PEPI Score 4
|
1 participants
|
—
|
—
|
|
Preoperative Endocrine Prognostic Index Score (PEPI Score)
PEPI Score 1
|
1 participants
|
—
|
—
|
|
Preoperative Endocrine Prognostic Index Score (PEPI Score)
PEPI Score 7
|
1 participants
|
—
|
—
|
|
Preoperative Endocrine Prognostic Index Score (PEPI Score)
PEPI Score 8
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: (1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.
Outcome measures
| Measure |
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
n=4 Participants
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
|
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Group 3 (E2 > 15 pg/ml)
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
|---|---|---|---|
|
PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less
|
0 percentage of participants
|
—
|
—
|
Adverse Events
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
Group 3 (E2 > 15 pg/ml)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Ki67 <10%, E2 <= 15 pg/ml)
n=6 participants at risk
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
|
Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)
n=1 participants at risk
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
Group 3 (E2 > 15 pg/ml)
n=1 participants at risk
Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
|
|---|---|---|---|
|
General disorders
Fatigue
|
100.0%
6/6
|
0.00%
0/1
|
0.00%
0/1
|
|
General disorders
Chills
|
50.0%
3/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Right heel pain
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Endocrine disorders
Hot flashes
|
100.0%
6/6
|
100.0%
1/1
|
100.0%
1/1
|
|
Endocrine disorders
Night sweats
|
83.3%
5/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Vascular disorders
Hypertension
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Psychiatric disorders
Insomnia
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Nervous system disorders
Headache
|
83.3%
5/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (joint)
|
100.0%
6/6
|
0.00%
0/1
|
100.0%
1/1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
3/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Irregular menstruation
|
83.3%
5/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Breast pain
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Skin and subcutaneous tissue disorders
Skin irritation around breast
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Vaginal dryness
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Psychiatric disorders
Depression
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
|
Immune system disorders
Allergic reaction
|
16.7%
1/6
|
0.00%
0/1
|
0.00%
0/1
|
Additional Information
Timothy Pluard, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place