Trial Outcomes & Findings for TRial on the Endocrine Activity of Neoadjuvant Degarelix (NCT NCT02005887)
NCT ID: NCT02005887
Last Updated: 2019-05-29
Results Overview
Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression (≤2.72 pg/mL or ≤10 pmol/L) during the 6 cycles of neoadjuvant treatments.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2019-05-29
Participant Flow
Participant milestones
| Measure |
Arm A: Triptorelin + Letrozol
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Arm A: Triptorelin + Letrozol
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=25 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.0 years
n=26 Participants
|
45.0 years
n=25 Participants
|
44.0 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=26 Participants
|
25 Participants
n=25 Participants
|
51 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=26 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Italy
|
26 Participants
n=26 Participants
|
25 Participants
n=25 Participants
|
51 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksTime from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression (≤2.72 pg/mL or ≤10 pmol/L) during the 6 cycles of neoadjuvant treatments.
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=25 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Time to Optimal Ovarian Function Suppression
|
14 days
Interval 8.0 to 14.0
|
3 days
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: Before day1 of cycle 1 and surgeryPopulation: Four patients are not evaluable: two patients did not undergo surgery during trial period, two patients did not have specimen submitted from surgery
The percent change in Ki67 expression from pre-treatment diagnostic (baseline) biopsy to surgery, calculated as (surgery-baseline)/baseline\*100.
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=25 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=22 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Ki67 Proliferation Marker Changes
|
-10.0 percentage change
Interval -15.0 to -5.0
|
-8.0 percentage change
Interval -15.8 to -4.2
|
SECONDARY outcome
Timeframe: After 24 weeks or the time of surgeryPopulation: Two patients who did not have surgery were not evaluated
Preoperative Endocrine Prognostic Index (PEPI) is the sum of the risk points (tumor size, nodal status, Ki67 level, ER status) with a 0-12 score representing the best prognostic feature (0 being the best score; 12 being the worst score), as previously determined to be associated with recurrence-free survival.
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=23 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Preoperative Endocrine Prognostic Index (PEPI) Score
|
6.5 scores on a scale
Interval 4.0 to 7.0
|
6.0 scores on a scale
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: From day 1 of cycle 1 across all time points until disease progressionBased on WHO tumor measurement and response criteria \[1\], measured from the start of treatment across all time points until disease progression or the end of 6 cycles of neoadjuvant therapies, whichever comes first. Response was determined by the IBCSG Head of Medical Affairs. An internal review (IR) form was created to record the final determination on best overall response. Confirmation of partial or complete response by an additional scan was not required in this trial. Best overall response was assessed based on changes in tumor size from baseline to the assessments after 3 and after 6 cycles (denoted as day 1 of cycle 4 and prior to surgery respectively) as measured physically by caliper or ruler and as measured by breast tumor imaging (i.e., bilateral mammography and breast ultrasound).
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=25 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Best Overall (Disease) Response
|
46.2 percentage of patients
Interval 30.1 to 62.2
|
44.0 percentage of patients
Interval 27.7 to 60.3
|
SECONDARY outcome
Timeframe: During surgery, an average of 2 hoursPopulation: Two patients who did not have surgery were not evaluated
The number of lymph nodes assessed at surgery minus the number of positives nodes identified, equal to zero.
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=23 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Percentage of Patients With Node-negative Disease at Surgery
|
34.6 percentage of patients
Interval 19.3 to 50.0
|
43.5 percentage of patients
Interval 26.5 to 60.5
|
SECONDARY outcome
Timeframe: During surgery, an average of 2 hoursPopulation: Two patients who did not have surgery were not evaluated
Whether or not patient undergoes BCS (per Surgery form).
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=23 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS)
|
42.3 percentage of patients
Interval 26.4 to 58.2
|
52.2 percentage of patients
Interval 35.0 to 69.3
|
SECONDARY outcome
Timeframe: At baseline, day 1 of cycle 2 and cycle 4 and prior to surgery; cycle 4 reportedPopulation: All patients who received at least one dose of trial treatment and had at least one FACT-ES assessment were included in the analysis
The patient-reported symptoms (PRS) will be assessed using the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) comprising 18 items (each has score range from 0 to 4) with a possible minimum total score of 0 and maximum total score of 72 (72 is best). Functional Assessment of Chronic Illness Therapy (FACIT) guidelines will be used for scoring and interpretation of the FACT-ES total score.
Outcome measures
| Measure |
Arm A: Triptorelin + Letrozol
n=26 Participants
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=25 Participants
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Patient-reported Symptoms (PRS) Outcomes
|
64 units on a scale
Interval 62.0 to 67.0
|
62 units on a scale
Interval 59.0 to 64.0
|
Adverse Events
Arm A: Triptorelin + Letrozol
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Arm B: Degarelix + Letrozol
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Triptorelin + Letrozol
n=26 participants at risk
Arm A: Triptorelin 3.75 mg i.m. on day 1 every 28 days for 6 cycles + letrozole 2.5 mg/day orally for 6 cycles
Triptorelin: Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
Arm B: Degarelix + Letrozol
n=25 participants at risk
Arm B: Degarelix 240 mg s.c. on day 1 of cycle 1, followed by 80 mg s.c. on day 1 of cycles 2 to 6 + letrozole 2.5 mg every day orally for 6 cycles
Degarelix: Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
Letrozole: Letrozole 2.5 mg orally every day for 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
0.00%
0/25 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
16.0%
4/25 • Number of events 4 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
General disorders
Fatigue
|
11.5%
3/26 • Number of events 3 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
4.0%
1/25 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
General disorders
Injection Site Reaction
|
0.00%
0/26 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
24.0%
6/25 • Number of events 7 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Investigations
Alanine Aminotransferase (ALT)
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
0.00%
0/25 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
53.8%
14/26 • Number of events 16 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
32.0%
8/25 • Number of events 9 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • Number of events 2 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
4.0%
1/25 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Psychiatric disorders
Anxiety
|
7.7%
2/26 • Number of events 2 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
8.0%
2/25 • Number of events 2 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Psychiatric disorders
Depression
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
8.0%
2/25 • Number of events 2 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Psychiatric disorders
Insomnia
|
11.5%
3/26 • Number of events 4 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
24.0%
6/25 • Number of events 6 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
4.0%
1/25 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Vascular disorders
Hot Flashes/Flushes
|
69.2%
18/26 • Number of events 18 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
80.0%
20/25 • Number of events 23 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Number of events 1 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
|
12.0%
3/25 • Number of events 3 • Adverse events (AE) forms were submitted at the end of every cycle (28 days) and 30 days after surgery. All patients submitted AE data during 6 cycles of treatment period when available.
Adverse events were collected using CTCAE v4.0. Each targeted AE will be classified according to the maximum grade of the event while on trial treatment (grade 0,1,2,3,4,5; where 0=no report). Other grade 3-5 AEs will be classified according to the maximum grade of any reported other AE.
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Additional Information
Meredith M. Regan
International Breast Cancer Study Group
Phone: +1 617-632-3012
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place