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New treatment option for Invasive Mammary Carcinoma
Official title Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
ClinicalTrials.gov ID: NCT05693766
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for invasive mammary carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed and dated written informed consent.
- people ≥ 18 years of age.
- 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:
- ER (\>/=1%) and/or PR (\>/= 1%) by IHC and HER2 negative (by IHC or FISH)
You likely can't join if
- Prior chemotherapy in the metastatic setting
- Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous...
- Persisting symptoms related to prior therapy that has not reduced to Grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events...
- Pregnant or breastfeeding females.
See the full eligibility criteria
- Signed and dated written informed consent.
- people ≥ 18 years of age.
- 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:
- ER (\>/=1%) and/or PR (\>/= 1%) by IHC and HER2 negative (by IHC or FISH)
- Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor.
- Prior radiation permitted (if completed at least 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)
- Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids
- Evaluable disease (measurable or non-measurable)
- Measurable disease, ie, at least 1 measurable lesion as per RECIST 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, MRI) even if lesions are non-measurable according to RECIST1.1.
- Adequate organ function including:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Platelets ≥ 100 × 10\^9/L
- Hemoglobin ≥ 8/g/dL (may have been transfused)
- Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)
- Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation
- For assigned by chance patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests
- Prior chemotherapy in the metastatic setting
- Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk...
- Persisting symptoms 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, menopausal symptoms, alopecia, and...
- Pregnant or breastfeeding females.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Nashville, Tennessee, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.