Trial Outcomes & Findings for Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer (NCT NCT01272037)
NCT ID: NCT01272037
Last Updated: 2025-11-10
Results Overview
From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
5018 participants
Primary outcome timeframe
5 years after randomization
Results posted on
2025-11-10
Participant Flow
9383 participants were screened and 5083 were randomized to the trial: 2547 to the Chemo and Endocrine Therapy arm and 2536 to the Endocrine Therapy Alone arm. In the Chemo and Endocrine Therapy Arm, 36 were ineligible. In the Endocrine Therapy Alone arm, 29 were ineligible. Ultimately, 5018 participants were eligible in the participant flow: 2511 in the Chemo and Endocrine Therapy arm and 2507 in the Endocrine Therapy Alone arm.
Participant milestones
| Measure |
Chemo and Endocrine Therapy
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
2511
|
2507
|
|
Overall Study
COMPLETED
|
1504
|
1547
|
|
Overall Study
NOT COMPLETED
|
1007
|
960
|
Reasons for withdrawal
| Measure |
Chemo and Endocrine Therapy
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Death
|
25
|
28
|
|
Overall Study
Adverse Event
|
12
|
7
|
|
Overall Study
Withdrawal by Subject
|
175
|
93
|
|
Overall Study
Disease progression
|
70
|
111
|
|
Overall Study
Other reason
|
42
|
41
|
|
Overall Study
Delinquent data
|
24
|
19
|
|
Overall Study
Reason under review
|
33
|
29
|
|
Overall Study
On treatment
|
626
|
632
|
Baseline Characteristics
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Baseline characteristics by cohort
| Measure |
Chemo and Endocrine Therapy
n=2511 Participants
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
n=2507 Participants
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Total
n=5018 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
n=5 Participants
|
57.2 years
n=20 Participants
|
57.5 years
n=40 Participants
|
|
Age, Customized
< 40 years
|
67 Participants
n=5 Participants
|
80 Participants
n=20 Participants
|
147 Participants
n=40 Participants
|
|
Age, Customized
40-49 years
|
530 Participants
n=5 Participants
|
547 Participants
n=20 Participants
|
1077 Participants
n=40 Participants
|
|
Age, Customized
50-59 years
|
837 Participants
n=5 Participants
|
838 Participants
n=20 Participants
|
1675 Participants
n=40 Participants
|
|
Age, Customized
60-69 years
|
777 Participants
n=5 Participants
|
761 Participants
n=20 Participants
|
1538 Participants
n=40 Participants
|
|
Age, Customized
>= 70 years
|
300 Participants
n=5 Participants
|
281 Participants
n=20 Participants
|
581 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
2511 Participants
n=5 Participants
|
2507 Participants
n=20 Participants
|
5018 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
297 Participants
n=5 Participants
|
325 Participants
n=20 Participants
|
622 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1731 Participants
n=5 Participants
|
1695 Participants
n=20 Participants
|
3426 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
483 Participants
n=5 Participants
|
487 Participants
n=20 Participants
|
970 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
1667 Participants
n=5 Participants
|
1628 Participants
n=20 Participants
|
3295 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
130 Participants
n=5 Participants
|
121 Participants
n=20 Participants
|
251 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
154 Participants
n=5 Participants
|
170 Participants
n=20 Participants
|
324 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other/Unknown
|
560 Participants
n=5 Participants
|
588 Participants
n=20 Participants
|
1148 Participants
n=40 Participants
|
|
Menopausal Status
Premenopausal
|
834 Participants
n=5 Participants
|
831 Participants
n=20 Participants
|
1665 Participants
n=40 Participants
|
|
Menopausal Status
Postmenopausal
|
1677 Participants
n=5 Participants
|
1676 Participants
n=20 Participants
|
3353 Participants
n=40 Participants
|
|
Recurrence Score
0-13
|
1076 Participants
n=5 Participants
|
1071 Participants
n=20 Participants
|
2147 Participants
n=40 Participants
|
|
Recurrence Score
14-25
|
1435 Participants
n=5 Participants
|
1436 Participants
n=20 Participants
|
2871 Participants
n=40 Participants
|
|
Axillary Surgery
Axillary lymph-node dissection, with or without sentinel-node mapping
|
1569 Participants
n=5 Participants
|
1571 Participants
n=20 Participants
|
3140 Participants
n=40 Participants
|
|
Axillary Surgery
Sentinel-node biopsy without axillary lymph-node dissection
|
942 Participants
n=5 Participants
|
936 Participants
n=20 Participants
|
1878 Participants
n=40 Participants
|
|
Positive Nodes
1 node
|
1628 Participants
n=5 Participants
|
1647 Participants
n=20 Participants
|
3275 Participants
n=40 Participants
|
|
Positive Nodes
2 nodes
|
643 Participants
n=5 Participants
|
623 Participants
n=20 Participants
|
1266 Participants
n=40 Participants
|
|
Positive Nodes
3 nodes
|
231 Participants
n=5 Participants
|
229 Participants
n=20 Participants
|
460 Participants
n=40 Participants
|
|
Positive Nodes
Not reported
|
9 Participants
n=5 Participants
|
8 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 5 years after randomizationPopulation: For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.
From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.
Outcome measures
| Measure |
Chemo and Endocrine Therapy
n=2487 Participants
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
n=2497 Participants
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Invasive Disease-Free Survival (IDFS)
Postmenopausal
|
91.3 percentage of participants
|
91.9 percentage of participants
|
|
Invasive Disease-Free Survival (IDFS)
Premenopausal
|
93.9 percentage of participants
|
89.0 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of treatment and follow-up until death or 3 years after randomizationPopulation: Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event.
Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization.
Outcome measures
| Measure |
Chemo and Endocrine Therapy
n=2062 Participants
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
n=2342 Participants
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyponatremia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypotension
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphocyte count decreased
|
20 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Menorrhagia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myelitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Supraventricular tachycardia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Surgical and medical procedures - Other, specify
|
2 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Typhlitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Upper gastrointestinal hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vomiting
|
19 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Acute kidney injury
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alanine aminotransferase increased
|
4 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Allergic reaction
|
6 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anemia
|
20 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anorexia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Anxiety
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Aspartate aminotransferase increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Atrial fibrillation
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Back pain
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Blood and lymphatic system disorders - Other
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bone marrow hypocellular
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bone pain
|
15 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Breast infection
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Bronchial infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
CD4 lymphocytes decreased
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cardiac arrest
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Cataract
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chest pain - cardiac
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Chest wall pain
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Colitis
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Constipation
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Death NOS
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dehydration
|
11 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Depression
|
3 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dermatitis radiation
|
4 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Device related infection
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dizziness
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dry mouth
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dry skin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspareunia
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspepsia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Dyspnea
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ear pain
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Edema limbs
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Ejection fraction decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erythema multiforme
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Erythroderma
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Esophagitis
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fatigue
|
48 Participants
|
9 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Febrile neutropenia
|
83 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flank pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Flu like symptoms
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
GGT increased
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastric hemorrhage
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
General disorders and admin site conditions - Other
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Generalized muscle weakness
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Headache
|
7 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Heart failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hematuria
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hemorrhoids
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperglycemia
|
16 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hyperhidrosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypertension
|
8 Participants
|
6 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hypokalemia
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
INR increased
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Infections and infestations - Other, specify
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Injection site reaction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Insomnia
|
9 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Irregular menstruation
|
3 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Joint range of motion decreased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Kidney infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Left ventricular systolic dysfunction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukemia secondary to oncology chemotherapy
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Leukocytosis
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lipase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Localized edema
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lung infection
|
6 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Lymphedema
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Mucositis oral
|
23 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Muscle weakness lower limb
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Musculoskeletal and connective tiss disorder - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myalgia
|
24 Participants
|
8 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Myocardial infarction
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nausea
|
21 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neck pain
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neoplasms benign, malignant and unspecified - Other
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Nervous system disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Neutrophil count decreased
|
150 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Osteoporosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pain in extremity
|
2 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Palmar-plantar erythrodysesthesia syndrome
|
7 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Paresthesia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral ischemia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral motor neuropathy
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Peripheral sensory neuropathy
|
21 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Platelet count decreased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pleuritic pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pneumonitis
|
8 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Premature menopause
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Pruritus
|
5 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Radiation recall reaction (dermatologic)
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash acneiform
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Rash maculo-papular
|
8 Participants
|
2 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Renal and urinary disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Reproductive system and breast disorders - Other
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sepsis
|
5 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Sinus tachycardia
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin and subcutaneous tissue disorders - Other
|
6 Participants
|
5 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin infection
|
9 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Skin ulceration
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Stroke
|
2 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Suicidal ideation
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Syncope
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Thromboembolic event
|
9 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Tinnitus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Upper respiratory infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urinary tract infection
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Urticaria
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Uterine hemorrhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginal dryness
|
0 Participants
|
4 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vaginal hemorrhage
|
1 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Vascular access complication
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Watering eyes
|
4 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight gain
|
4 Participants
|
1 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Weight loss
|
2 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
White blood cell decreased
|
65 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Wound dehiscence
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hot flashes
|
12 Participants
|
14 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Alkaline phosphatase increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Arthralgia
|
48 Participants
|
35 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Catheter related infection
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Diarrhea
|
31 Participants
|
3 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Fever
|
3 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastric ulcer
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Gastrointestinal disorders - Other, specify
|
1 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal pain
|
7 Participants
|
0 Participants
|
|
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Abdominal infection
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5.5 years after randomizationTime from date of randomization (2nd Registration) to date of death due to any cause. Participants last known to be alive are censored at their last contact date.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5.5 years after randomizationTime from date of randomization (2nd Registration) to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Participants last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. This secondary outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of randomization to a maximum of 5.5 years or deathTime from date of randomization (2nd Registration) to date of invasive local or regional recurrence. Participants last known to be alive without recurrence are censored at their last contact date. Participants with distant recurrence, second primary cancer or death are censored at the time of that event. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after randomizationAnxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after randomizationAssessed using the EuroQol-5D (EQ-5D), in which participants rate their health status in five different health-related domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw scores can be converted to index scores on a scale of 0 to 1, where a higher index score represents better health. EQ-5D index scores at the 6-month timepoint will be compared between the two randomized study arms separately by menopausal status.
Outcome measures
Outcome data not reported
POST_HOC outcome
Timeframe: 5 years after randomizationPopulation: Eligible and evaluable participants
Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence or death due to any cause. Participants last known to be alive who have not experienced distant recurrence are censored at their last contact date. This outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Kaplan-Meier estimates were calculated for the 5-year DRFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status. The NCI and the data and safety monitoring committee recommended early reporting of the data. Due to subsequent data collection and data cleaning, the population of eligible and evaluable participants differs slightly between the reporting of this outcome and the Participant Flow section.
Outcome measures
| Measure |
Chemo and Endocrine Therapy
n=2487 Participants
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Endocrine Therapy Alone
n=2497 Participants
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Distant Relapse-Free Survival (DRFS)
Premenopausal participants
|
96.1 percentage of participants
|
92.8 percentage of participants
|
|
Distant Relapse-Free Survival (DRFS)
Postmenopausal participants
|
94.4 percentage of participants
|
94.4 percentage of participants
|
Adverse Events
Endocrine Therapy Alone
Serious events: 9 serious events
Other events: 2 other events
Deaths: 175 deaths
Chemo and Endocrine Therapy
Serious events: 14 serious events
Other events: 151 other events
Deaths: 161 deaths
Serious adverse events
| Measure |
Endocrine Therapy Alone
n=2342 participants at risk
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Chemo and Endocrine Therapy
n=2062 participants at risk
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
2/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.10%
2/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Gastrointestinal disorders
Gastrointestinal disorders-Other
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
General disorders
Death NOS
|
0.04%
1/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
General disorders
Multi-organ failure
|
0.04%
1/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.00%
0/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.15%
3/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Injury, poisoning and procedural complications
Injury, poison and procedural complications - Other
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.05%
1/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.04%
1/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.00%
0/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Nervous system disorders
Stroke
|
0.13%
3/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.00%
0/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions-Other
|
0.04%
1/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.00%
0/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
0.10%
2/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
Other adverse events
| Measure |
Endocrine Therapy Alone
n=2342 participants at risk
Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
Chemo and Endocrine Therapy
n=2062 participants at risk
Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.09%
2/2342 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
7.3%
151/2062 • Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
|
Additional Information
Breast Committee Statistician
SWOG Statistics and Data Management Center
Phone: 206-667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60