gynaecologische neoplasmata breast cancer gynaecological cancer
Conditions
Interventions
carboplatin AUC 5mg/ml*min, cyclophosphamide 600mg/m2 and atezolizumab 840 mg,
all administered intravenously.
One cycle is 28 days.
On day 1 carboplatin, cyclophosphamide and atezolizumab will be
advanced
breast cancer
gynaecological cancer
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Histological or cytological proof of advanced breast cancer (M1) or gynaecological (cervix (M1, FIGO IVA/IVB), ovarian (after recurrence on carboplatin and/or paclitaxel) or endometrial (T3-T4, FIGO IVA/IVB) cancer) cancer pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal therapy for advanced disease and potentially benefitting from carboplatin-cyclophosphamide and atezolizumab. (prior (neo-) adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease); 2. Maximally one line of platinum containing pre-treatment is allowed in either adjuvant or metastatic setting 3. Men and women >=18 years; 4. Able and willing to give written informed consent; 5. WHO performance status of 0 or 1; 6. Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity; 7. Minimal acceptable safety laboratory values
Exclusion criteria
Exclusion criteria: 1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy; 2. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease; 3. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies. 4. Women who have a positive pregnancy test (urine/serum) and/or who ware breast feeding; 5. Unreliable contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To determine a safe dose combination of carboplatin-cyclophosphamide combined with atezolizumab fixed dose in patients with advanced breast cancer and gynecologic cancer (ovarian, cervical and endometrial cancer). | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the tolerability of carboplatin-cyclophosphamide in combination with atezolizumab; • To assess preliminary antitumor activity of carboplatin-cyclophosphamide combined with atezolizumab in advanced breast cancer, ovarian, cervical and endometrial cancer. | — |
Countries
The Netherlands
Outcome results
None listed