Breast Cancer
Conditions
Brief summary
This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.
Interventions
DRUGRG1507
R1507 was administered at a dose 16 mg/kg every 3 weeks.
DRUGLetrozole
Letrozole was administered orally at a dose 2.5 mg daily.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postmenopausal female patients; * stage IV or locally advanced breast cancer; * measurable disease; * letrozole failure (Part 2); * Eastern Cooperative Oncology Group (ECOG) performance status \<=2.
Exclusion criteria
* previous chemotherapy for metastatic breast cancer; * concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug; * history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix; * concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Tumor Response (Part 2) | Up to 14 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) Profile (Part 2) | Up to 14 months |
| Progression-free Survival (Part 2) | Up to 14 months |
| Number of Participants With Adverse Events (Part 2) | Up to 14 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| R1507 in Combination With Letrozole Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Progressive Disease | 5 |
Baseline characteristics
| Characteristic | R1507 in Combination With Letrozole |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 1 / 6 |
Outcome results
Primary
Objective Tumor Response (Part 2)
Time frame: Up to 14 months
Population: Phase 2 of this study was not conducted.
Secondary
Number of Participants With Adverse Events (Part 2)
Time frame: Up to 14 months
Population: Since Phase 2 of this study was not conducted, this outcome measure was not collected.
Secondary
Pharmacokinetics (PK) Profile (Part 2)
Time frame: Up to 14 months
Population: Phase 2 of this study was not conducted.
Secondary
Progression-free Survival (Part 2)
Time frame: Up to 14 months
Population: Phase 2 of this study was not conducted.