Trial Outcomes & Findings for Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer (NCT NCT00553410)

Last Updated: 2020-03-11

Results Overview

Duration of time from randomization to the first indication of the following events: invasive recurrence at local (including recurrence restricted to the breast after breast conserving treatment), regional or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) invasive malignancy; or a death without prior cancer event. Appearance of DCIS or LCIS either in the ipsilateral or in the contralateral breast was not be considered as an event for DFS. In the absence of an event, DFS was censored at the date of last follow-up visit.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4884 participants

Primary outcome timeframe

5-year estimates, reported at a median follow-up of 60 months

Results posted on

2020-03-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Continuous Letrozole Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Overall Study STARTED	2441	2443
Overall Study COMPLETED	2426	2425
Overall Study NOT COMPLETED	15	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Continuous Letrozole n=2426 Participants Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2425 Participants Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months	Total n=4851 Participants Total of all reporting groups
Age, Customized <55	668 Participants n=5 Participants	671 Participants n=7 Participants	1339 Participants n=5 Participants
Age, Customized 55-59	504 Participants n=5 Participants	496 Participants n=7 Participants	1000 Participants n=5 Participants
Age, Customized 60-64	451 Participants n=5 Participants	471 Participants n=7 Participants	922 Participants n=5 Participants
Age, Customized 65-69	400 Participants n=5 Participants	375 Participants n=7 Participants	775 Participants n=5 Participants
Age, Customized 70+	383 Participants n=5 Participants	412 Participants n=7 Participants	795 Participants n=5 Participants
Sex: Female, Male Female	2426 Participants n=5 Participants	2425 Participants n=7 Participants	4851 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	2199 Participants n=5 Participants	2211 Participants n=7 Participants	4410 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian	119 Participants n=5 Participants	121 Participants n=7 Participants	240 Participants n=5 Participants
Race/Ethnicity, Customized Other	97 Participants n=5 Participants	83 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Hungary	78 participants n=5 Participants	77 participants n=7 Participants	155 participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	19 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Japan	93 participants n=5 Participants	99 participants n=7 Participants	192 participants n=5 Participants
Region of Enrollment United Kingdom	217 participants n=5 Participants	216 participants n=7 Participants	433 participants n=5 Participants
Region of Enrollment Switzerland	159 participants n=5 Participants	159 participants n=7 Participants	318 participants n=5 Participants
Region of Enrollment India	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Russia	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants
Region of Enrollment Spain	137 participants n=5 Participants	134 participants n=7 Participants	271 participants n=5 Participants
Region of Enrollment New Zealand	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Austria	88 participants n=5 Participants	92 participants n=7 Participants	180 participants n=5 Participants
Region of Enrollment Sweden	104 participants n=5 Participants	105 participants n=7 Participants	209 participants n=5 Participants
Region of Enrollment Belgium	509 participants n=5 Participants	520 participants n=7 Participants	1029 participants n=5 Participants
Region of Enrollment Denmark	223 participants n=5 Participants	218 participants n=7 Participants	441 participants n=5 Participants
Region of Enrollment Italy	287 participants n=5 Participants	291 participants n=7 Participants	578 participants n=5 Participants
Region of Enrollment South Africa	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants
Region of Enrollment Australia	182 participants n=5 Participants	171 participants n=7 Participants	353 participants n=5 Participants
Region of Enrollment Chile	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants
Region of Enrollment France	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Peru	33 participants n=5 Participants	33 participants n=7 Participants	66 participants n=5 Participants
Region of Enrollment Germany	146 participants n=5 Participants	145 participants n=7 Participants	291 participants n=5 Participants

PRIMARY outcome

Timeframe: 5-year estimates, reported at a median follow-up of 60 months

Population: Intention-to-treat

Outcome measures

Outcome measures
Measure	Arm A: Continuous Letrozole n=2426 Participants Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2425 Participants Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Disease-free Survival (DFS)	87.5 percentage of patients Interval 86.0 to 88.8	85.8 percentage of patients Interval 84.2 to 87.2

SECONDARY outcome

Timeframe: 5-year estimates, reported at a median follow-up of 60 months

Population: Intention-to-treat

Duration of time from randomization to death from any cause, or was censored at the date last known alive. (Note, for patients who withdrew consent or were lost to follow-up but follow-up for survival was possible through hospital or registry records, OS was censored at the date last known alive rather than date of last follow-up/withdrawn consent).

Outcome measures

Outcome measures
Measure	Arm A: Continuous Letrozole n=2426 Participants Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2425 Participants Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Overall Survival	93.7 percentage of patients Interval 92.6 to 94.7	94.3 percentage of patients Interval 93.2 to 95.2

SECONDARY outcome

Timeframe: 5-year estimates, reported at a median follow-up of 60 months

Population: Intention-to-treat

Duration of time from randomization to the first indication of invasive breast recurrence at a distant site. In the absence of an event, DRFI was censored at the date of last follow-up visit or date or death without distant recurrence.\* \*This endpoint replaced DDFS, which was specified in the protocol

Outcome measures

Outcome measures
Measure	Arm A: Continuous Letrozole n=2426 Participants Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2425 Participants Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Distant Recurrence-free Interval (DRFI)	92.5 percentage of patients Interval 91.3 to 93.5	93.2 percentage of patients Interval 92.0 to 94.2

SECONDARY outcome

Timeframe: 5-year estimates, reported at a median follow-up of 60 months

Population: Intention-to-treat

Duration of time from randomization to the first indication of the following events: invasive breast recurrence at local, regional or distant sites; a new invasive cancer in the contralateral breast (second non-breast malignancies are ignored). In the absence of an event, BCFI was censored at the date of last follow-up visit or date of death without prior breast cancer event.

Outcome measures

Outcome measures
Measure	Arm A: Continuous Letrozole n=2426 Participants Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2425 Participants Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Breast Cancer-free Interval	91.2 percentage of patients Interval 89.9 to 92.3	90.9 percentage of patients Interval 89.6 to 92.1

Adverse Events

Arm A: Continuous Letrozole

Serious events: 1004 serious events

Other events: 2257 other events

Deaths: 170 deaths

Arm B: Intermittent Letrozole

Serious events: 1052 serious events

Other events: 2261 other events

Deaths: 146 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm A: Continuous Letrozole n=2411 participants at risk Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously	Arm B: Intermittent Letrozole n=2417 participants at risk Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
Cardiac disorders Cardiac-ischemia/infarction	0.62% 15/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	0.95% 23/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
General disorders Fatigue (asthenia, lethargy, malaise)	42.5% 1025/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	39.5% 954/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Injury, poisoning and procedural complications Fracture	6.1% 148/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	5.6% 136/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Injury, poisoning and procedural complications Thrombosis/embolism (vascular access-related)	0.33% 8/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	0.37% 9/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Musculoskeletal and connective tissue disorders Osteoporosis	46.2% 1113/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	46.3% 1119/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Musculoskeletal and connective tissue disorders Pain - Bone	26.3% 634/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	25.4% 613/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Musculoskeletal and connective tissue disorders Pain - Joint	62.5% 1506/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	60.1% 1453/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Musculoskeletal and connective tissue disorders Pain - Muscle	34.9% 841/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	33.8% 818/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Nervous system disorders Hemorrhage, CNS	0.17% 4/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	0.17% 4/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Nervous system disorders CNS cerebrovascular ischemia	0.46% 11/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	0.33% 8/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Psychiatric disorders Insomnia	40.8% 983/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	39.8% 961/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Psychiatric disorders Mood alteration - depression	31.8% 767/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	31.5% 762/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Vascular disorders Hot flashes/flushes	51.4% 1240/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	50.4% 1217/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
Vascular disorders Hypertension	22.4% 539/2411 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.	20.4% 493/2417 • during or within 30 days after stopping study treatment Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.

Additional Information

Meredith M. Regan

International Breast Cancer Study Group (IBCSG)

Phone: +1 617 632 3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place