Trial Outcomes & Findings for Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy (NCT NCT00053898)

NCT ID: NCT00053898

Last Updated: 2018-09-20

Results Overview

Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3104 participants
• Primary outcome timeframe: 10 years
• Results posted on: 2018-09-20

Participant Flow

Participant milestones

Measure	Group 1: Tamoxifen + Anastrozole Placebo tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Overall Study STARTED	1552	1552
Overall Study COMPLETED	1538	1539
Overall Study NOT COMPLETED	14	13

Reasons for withdrawal

Measure	Group 1: Tamoxifen + Anastrozole Placebo tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Overall Study No follow-up data from any source	9	12
Overall Study Follow-up from telephone contact only	5	1

Baseline Characteristics

Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy

Baseline characteristics by cohort

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1552 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years Drug: tamoxifen citrate 20 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1552 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years Drug: anastrozole 1 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy	Total n=3104 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 7.8 • n=5 Participants	61.1 years STANDARD_DEVIATION 7.8 • n=7 Participants	61.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	1552 Participants n=5 Participants	1552 Participants n=7 Participants	3104 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years

Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Breast Cancer	89.1 percentage of participants event-free	93.1 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Invasive Breast Cancer	93.3 percentage of participants event-free	96.4 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Ipsilateral Recurrence	94.6 percentage of participants event-free	96.4 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Contralateral Breast Cancer	94.7 percentage of participants event-free	97.0 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Non-breast Secondary Cancer	91.5 percentage of participants event-free	91.9 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Population: The analysis for osteoporotic fractures included those whose method of contact for follow-up was by telephone. Two participants were excluded from the analysis because their date of fracture was unknown.

Percentage of patients free from fractures of the hip, spine, and wrist.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1542 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Free From Osteoporotic Fractures	96.0 percentage of participants event-free	95.3 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Alive and Disease-free	77.9 percentage of participants event-free	82.7 percentage of participants event-free

SECONDARY outcome

Timeframe: 10 years

Population: The analysis for overall survival included those whose method of contact for follow-up was by telephone.

Percentage of patients alive.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1543 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1540 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Percentage of Patients Alive (Overall Survival)	92.1 percentage of participants event-free	92.5 percentage of participants event-free

SECONDARY outcome

Timeframe: 5 years

Population: The Quality of Life study was performed in a subset of B-35 participants. Participants were required to have submitted a baseline and at least one follow-up QOL form to be included in the analysis.

The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=601 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=592 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Quality of Life-Short Form 12 (SF-12) Physical Health Component Score	46.20 units on a scale Standard Deviation 10.13	45.38 units on a scale Standard Deviation 10.25

SECONDARY outcome

Timeframe: 10 years

The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.

Outcome measures

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1538 Participants tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years tamoxifen citrate: 20 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy	Group 2: Anastrozole + Tamoxifen Placebo n=1539 Participants anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years anastrozole: 1 mg/day and placebo for 5 years Radiation Therapy: Adjuvant radiation therapy
Quality-adjusted Survival Time	104.4 months Interval 101.8 to 106.9	102.9 months Interval 100.9 to 104.9

Adverse Events

Group 1: Tamoxifen + Anastrozole Placebo

Serious events: 73 serious events

Other events: 1024 other events

Deaths: 0 deaths

Group 2: Anastrazole + Tamoxifen Placebo

Serious events: 62 serious events

Other events: 1064 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1535 participants at risk tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years Drug: tamoxifen citrate 20 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy	Group 2: Anastrazole + Tamoxifen Placebo n=1535 participants at risk anastrozole, 1 mg/day and a tamoxifen look-alike placebo for 5 years Drug: anastrozole 1 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy
Gastrointestinal disorders Abdominal pain	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Anxiety	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Arthralgia	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Aspartate aminotransferase increased (AST/SGOT)	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Blood antidiuretic hormone abnormal	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Cardiac arrest	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Cardiac disorders - Other, specify	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin I increased	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.	0.33% 5/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Cardiac troponin T increased	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Cholesterol high	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Colitis	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Confusion	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations CPK increased	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Creatinine increased	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.46% 7/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Death NOS	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Dehydration	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Depression	0.33% 5/1535 Participants at Risk includes any patient who submitted an AE form.	0.33% 5/1535 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Diarrhea	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Eye disorders Eye disorders - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Gastric ulcer	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Headache	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Heart failure	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hypertension	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypertriglyceridemia	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypocalcemia	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypokalemia	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyponatremia	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.52% 8/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Intracranial hemorrhage	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Investigations - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Myocardial infarction	0.39% 6/1535 Participants at Risk includes any patient who submitted an AE form.	0.52% 8/1535 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Nervous system disorders - Other, specify	0.46% 7/1535 Participants at Risk includes any patient who submitted an AE form.	0.46% 7/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Neuralgia	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Pain	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Personality change	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations Platelet count decreased	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Seizure	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Stroke	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Sudden death NOS	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Supraventricular tachycardia	0.33% 5/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Syncope	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Thromboembolic event	1.3% 20/1535 Participants at Risk includes any patient who submitted an AE form.	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Urinary incontinence	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Vascular disorders - Other, specify	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Ventricular arrhythmia	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Wound infection	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Edema limbs	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Acute coronary syndrome	0.26% 4/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Investigations GGT increased	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Lung infection	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Urinary tract obstruction	0.20% 3/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Avascular necrosis	0.00% 0/1535 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Acute kidney injury	0.07% 1/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Left ventricular systolic dysfunction	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.	0.13% 2/1535 Participants at Risk includes any patient who submitted an AE form.

Other adverse events

Measure	Group 1: Tamoxifen + Anastrozole Placebo n=1535 participants at risk tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years Drug: tamoxifen citrate 20 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy	Group 2: Anastrazole + Tamoxifen Placebo n=1535 participants at risk anastrozole, 1 mg/day and a tamoxifen look-alike placebo for 5 years Drug: anastrozole 1 mg/day and placebo for 5 years Radiation: Radiation Therapy Adjuvant radiation therapy
Musculoskeletal and connective tissue disorders Arthralgia	23.3% 358/1535 Participants at Risk includes any patient who submitted an AE form.	32.8% 504/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Bone pain	6.3% 96/1535 Participants at Risk includes any patient who submitted an AE form.	9.9% 152/1535 Participants at Risk includes any patient who submitted an AE form.
Eye disorders Cataract	5.0% 77/1535 Participants at Risk includes any patient who submitted an AE form.	2.8% 43/1535 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Depression	7.3% 112/1535 Participants at Risk includes any patient who submitted an AE form.	8.2% 126/1535 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.6% 101/1535 Participants at Risk includes any patient who submitted an AE form.	6.2% 95/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	12.2% 187/1535 Participants at Risk includes any patient who submitted an AE form.	12.8% 196/1535 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Headache	4.8% 73/1535 Participants at Risk includes any patient who submitted an AE form.	5.6% 86/1535 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Hot flashes	42.7% 655/1535 Participants at Risk includes any patient who submitted an AE form.	37.1% 570/1535 Participants at Risk includes any patient who submitted an AE form.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.1% 124/1535 Participants at Risk includes any patient who submitted an AE form.	6.4% 99/1535 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	14.1% 216/1535 Participants at Risk includes any patient who submitted an AE form.	13.5% 207/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.6% 55/1535 Participants at Risk includes any patient who submitted an AE form.	5.9% 91/1535 Participants at Risk includes any patient who submitted an AE form.
Musculoskeletal and connective tissue disorders Myalgia	10.9% 168/1535 Participants at Risk includes any patient who submitted an AE form.	14.2% 218/1535 Participants at Risk includes any patient who submitted an AE form.
General disorders Pain	5.1% 78/1535 Participants at Risk includes any patient who submitted an AE form.	5.7% 88/1535 Participants at Risk includes any patient who submitted an AE form.
Reproductive system and breast disorders Vaginal dryness	8.9% 137/1535 Participants at Risk includes any patient who submitted an AE form.	12.8% 197/1535 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Department of Regulatory Affairs

NSABP Foundation, Inc

Phone: 412-339-5300

Email: regulatory@nsabp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60