Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer
Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer
This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.
Breast
Phase II
Adults
Chemotherapy - cytotoxic,
Hormonal Therapy
Capecitabine
Reid, Sonya
Local
UT Southwestern Medical Center, University of Alabama - Birmingham, Vanderbilt University
03-31-2023
Eligibility
18 Years
FEMALE
NO
Inclusion Criteria:
Signed and dated written informed consent.
Subjects >= 18 years of age at time of signing informed consent; only participants who were born female.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is: * Estrogen receptor (ER)-positive/ progesterone receptor (PR)-positive (positive defined as > 1% cells) by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) negative (by IHC or fluorescence in situ hybridization [FISH]).
Previously progressed on: * An aromatase inhibitor (AI) + CDK4/6 inhibitor, OR * A selective estrogen-receptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
Evaluable disease (measurable or non-measurable). * Measurable disease ie, at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation). * Patients with bone only disease allowed if possible to evaluate on radiological exams (eg. bone scan, PET/CT, CT, magnetic resonance imaging [MRI]) even if lesions are non-measurable according to RECIST 1.1.
Absolute neutrophil count (ANC) >= 1.5 10^9/L.
Platelets >= 100 10^9/L.
Hemoglobin >= 9/g/dL (may have been transfused).
Total serum bilirubin = 1.5 times upper limit of normal (ULN).
Aspartate aminotransferase (AST/ serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/ serum glutamic-pyruvic transaminase [SGPT]) = 2.5 ULN (or = 5 ULN if liver metastases are present).
Serum creatinine = 1.5 x ULN or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation.
FOR RANDOMIZED PATIENTS ONLY: tumors must be diagnosed as non-Luminal A using the Blueprint registered trademark and Mammaprint registered trademark tests.
Exclusion Criteria:
PIK3CA mutation.
Prior chemotherapy in the metastatic setting.
More than 1 prior line of endocrine therapy in the metastatic setting.
Radiation therapy = 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (= grade 1) induced by this treatment (except for alopecia).
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment and off steroids).
Persisting toxicity related to prior therapy that has not reduced to grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, alopecia, sensory neuropathy, or arthralgia Grade = 2 is acceptable.
Pregnant or breastfeeding females.
Signed and dated written informed consent.
Subjects >= 18 years of age at time of signing informed consent; only participants who were born female.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is: * Estrogen receptor (ER)-positive/ progesterone receptor (PR)-positive (positive defined as > 1% cells) by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) negative (by IHC or fluorescence in situ hybridization [FISH]).
Previously progressed on: * An aromatase inhibitor (AI) + CDK4/6 inhibitor, OR * A selective estrogen-receptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
Evaluable disease (measurable or non-measurable). * Measurable disease ie, at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation). * Patients with bone only disease allowed if possible to evaluate on radiological exams (eg. bone scan, PET/CT, CT, magnetic resonance imaging [MRI]) even if lesions are non-measurable according to RECIST 1.1.
Absolute neutrophil count (ANC) >= 1.5 10^9/L.
Platelets >= 100 10^9/L.
Hemoglobin >= 9/g/dL (may have been transfused).
Total serum bilirubin = 1.5 times upper limit of normal (ULN).
Aspartate aminotransferase (AST/ serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT/ serum glutamic-pyruvic transaminase [SGPT]) = 2.5 ULN (or = 5 ULN if liver metastases are present).
Serum creatinine = 1.5 x ULN or estimated creatinine clearance >= 50 mL/min as calculated using the Cockcroft-Gault (CG) equation.
FOR RANDOMIZED PATIENTS ONLY: tumors must be diagnosed as non-Luminal A using the Blueprint registered trademark and Mammaprint registered trademark tests.
Exclusion Criteria:
PIK3CA mutation.
Prior chemotherapy in the metastatic setting.
More than 1 prior line of endocrine therapy in the metastatic setting.
Radiation therapy = 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (= grade 1) induced by this treatment (except for alopecia).
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment and off steroids).
Persisting toxicity related to prior therapy that has not reduced to grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, alopecia, sensory neuropathy, or arthralgia Grade = 2 is acceptable.
Pregnant or breastfeeding females.
