A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy

Phase 2

Completed

Conditions: ER-positive breast cancer
Metastatic breast cancer
Her2 negative
10006291

Registration Number: NL-OMON52884

Lead Sponsor: BOOG Study Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Adult women(>= 18 years of age) with proven diagnosis of metastatic or
locally advanced breast cancer not amenable to curative treatment by surgery or
radiotherapy
2. Documented ER positive (10%) / PR positive (10%) and HER2 negative
metastatic breast cancer
3. Progressive disease based on imaging
4. Women previously treated with capecitabine (in metastatic setting), and a
maximum of two other lines of chemotherapy including a
taxane either in the (neo)adjuvant or metastatic setting.
5. Evaluable disease as defined per RECIST v.1.1 (see Appendix A). Tumor lesions
previously irradiated or subjected to other locoregional therapy will
only be deemed
measurable if disease progression at the treated site after completion
of therapy is
clearly documented.
6. Eastern Cooperative Oncology Group (ECOG) performance status<= 1
7. Life expectancy of >= 12 weeks
8. Willing and able to comply with scheduled visits and study procedures
9. Adequate organ, bone marrow and coagulation function as shown by:
• Absolute neutrophil count (ANC) >= 1.5 ×109/L
• Platelets >= 75 ×109/L
• Hemoglobin (Hgb) >= 5.6 mmol/L
• Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=
2.5 ULN (or <= 5 if hepatic metastases are present)
• Total serum bilirubin <= 1.5 × ULN (<= 3 × ULN for patients known to have
Gilbert Syndrome)
• Creatinine clearance >=60 ml/min
10. Written informed consent obtained before any screening procedure and
according to local guidelines.
11. Resolution of all acute toxic effects of prior anti-cancer therapy or
surgical procedures to NCI CTCAE version 4.0 Grade <=1, except
alopecia or other toxicities not considered a safety risk for the
patient at investigator's discretion.

Exclusion Criteria

1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or
in situ hybridization positive) and ER-negative patients are not eligible
2. No more than two lines of chemotherapy for advanced disease
3. Remaining of side-effects from previous chemotherapy > grade 1 (except for
alopecia)
4. Radiotherapy within four weeks prior to enrollment is not allowed except in
case of localized radiotherapy for analgesic purpose or for lytic lesions at
risk of fracture which can then be completed within two weeks prior to
enrollment. Patients must have recovered from radiotherapy toxicities prior to
enrollment.
5. 30% or more marrow-bearing bone being irradiated. Other primary tumors
within the last 5 years before study entry are not allowed, except for
adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of
the cervix.
6. Previous or current CNS metastases, carcinomatous meningitis, are not
allowed. A CT or MRI of the brain must be performed within 4 weeks prior to
registration if the presence of metastases at this site is suspected.
7. Evidence of clinically significant cardiovascular or pulmonary disease or
any other disease, metabolic or psychological dysfunction, physical examination
finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug,
or that may affect patient compliance with study routines, or places the
patient at high risk from treatment related complications. (e.g lactose
intolerance)
8. Previously received trifluridine/tipiracil
9. Since trifluridine/tipiracil contains lactose, patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicine (see section 4.4
of the SmPC). (APPENDIX B)
10. Diagnosis of any other malignancy prior to registration, except those that
are not believed to influence the patient*s prognosis and do not require any
further treatment.
11. Other severe acute or chronic medical or psychiatric condition or
laboratory abnormality that may increase the risk associated with study
participation or investigational product administration or may interfere with
the interpretation of study results and, in the judgment of the investigator,
would make the patient inappropriate for entry into this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients being progression free at 8 weeks on<br /><br>trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced<br /><br>breast cancer patients previously treated with a taxane and capecitabine</p><br>

Secondary Outcome Measures