Breast Cancer
Conditions
Keywords
Breast neoplasms, breast cancer, early breast cancer, oncology, cancer, breast cancer micrometastasis, fulvestrant
Brief summary
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.
Interventions
DRUGFulvestrant
intramuscular injection
DRUGAnastrozole
1 mg oral tablet
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation
Exclusion criteria
* Inflammatory and/or metastatic breast cancer. * Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer). * History of bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | 12 month period following randomisation | Number of patients event-free |
Countries
Austria, Germany, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fulvestrant + Anastrozole fulvestrant 500 mg + anastrozole 1 mg | 6 |
| Anastrozole anastrozole 1 mg | 7 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Early study termination | 5 | 5 |
Baseline characteristics
| Characteristic | Fulvestrant + Anastrozole | Anastrozole | Total |
|---|---|---|---|
| Age Continuous | 60.5 age in years at baseline STANDARD_DEVIATION 5.4 | 63.4 age in years at baseline STANDARD_DEVIATION 3.5 | 62.1 age in years at baseline STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 6 | 5 / 7 |
| serious Total, serious adverse events | 1 / 6 | 2 / 7 |
Outcome results
Primary
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
Number of patients event-free
Time frame: 12 month period following randomisation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fulvestrant + Anastrozole | Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | 6 Participants |
| Anastrozole | Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | 7 Participants |