Study Comparing Sacituzumab Govitecan to Standard Treatments for HR+/HER2- Metastatic Breast Cancer

Inclusion Criteria

• Able to understand and sign a consent form.
• Have a tumor sample from a recurrent or metastatic site.
• Confirmed HR+ metastatic breast cancer from a recent biopsy.
• Confirmed HER2- status.
• Cancer progression shown by CT or MRI scans during or after recent therapy.
• Ready for first chemotherapy in advanced cancer setting.
• Eligible for treatments like capecitabine, nab-paclitaxel, or paclitaxel.
• Must meet one of the following:
  • Cancer worsened after at least two previous hormone therapies, with or without targeted therapy.
  • Cancer returned within 24 months of starting hormone therapy, needing only one line of therapy in advanced setting.
  • Cancer worsened within 6 months of starting first-line hormone therapy with or without a CDK 4/6 inhibitor.
  • Cancer returned within 24 months of starting hormone therapy with CDK 4/6 inhibitor and no longer a candidate for more hormone therapy.
• May have had previous targeted therapies but cannot continue with more hormone treatments.
• If HIV positive, must be on treatment and have well-controlled HIV.
• Must have good organ function.
• Must agree to use contraception if sexually active.
• Must have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

• Cancer worsened within 6 months of finishing chemotherapy.
• Advanced breast cancer that can be treated with curative intent.
• Currently in another clinical study or using investigational drugs recently.
• Previously treated with certain chemotherapy agents targeting topoisomerase I.
• Previously treated with Trop-2-directed therapies.
• Have another active cancer.
• Have a serious infection needing antibiotics.
• Have active hepatitis B or C.
• HIV positive with a history of certain diseases.
• Pregnant or breastfeeding individuals.