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New treatment option for Breast Cancer
Official title Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
ClinicalTrials.gov ID: NCT06263543
What this study is testing
What is Sacituzumab govitecan?
Sacituzumab govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Also referred to as Trodelvy.
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
- The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.
- Phase 2: a mid-size study of how well it works
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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals ≥ 18 years of age.
- 4\. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing on either the primary...
- Histologically confirmed metastatic or advanced and unresectable breast cancer that is hormone receptor positive (estrogen receptor and/or...
You likely can't join if
- Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on...
- Active serious infection requiring ongoing antibiotics.
- History of an anaphylactic reaction to irinotecan.
- Pregnant or breastfeeding.
- Ongoing treatment with another investigational drug or other treatment trial.
See the full eligibility criteria
Who can join
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals ≥ 18 years of age.
- 4\. Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2 LOW/ULTRA LOW by local testing on either the primary or any metastatic site. HER2 LOW is defined as: (IHC 2+/ISH- or IHC 1+...
- Histologically confirmed metastatic or advanced and unresectable breast cancer that is hormone receptor positive (estrogen receptor and/or progesterone receptor positive) defined as \>1% on any metastatic site or the...
- Endocrine-refractory (as per investigator judgement) and may have received any number of prior endocrine therapies (alone or in combination with cyclin-dependent kinase (CDK)4/6 inhibitor, everolimus, alpelisib...
- Received a CDK4/6 inhibitor either alone or in combination with endocrine therapy (in the adjuvant or metastatic setting) with any duration of therapy permitted.
- Received at least 1 but no more than 4 prior systemic chemotherapy regimens in the metastatic setting. Prior ADCs count as a line of systemic chemotherapy. Prior PARP inhibitor use counts as a line of systemic therapy.
- Prior treatment with T-DXd (discontinued for progression and/or intolerance), which does not have to be the treatment immediately prior to enrollment on trial.
- Documented clinical and/or radiographic disease progression after most recent therapy, unless immediate prior therapy was T-DXd which was discontinued for toxicity.
- Measurable disease, as per RECIST V1.1 - a. If a patient has bone-only disease, they are eligible as long as there is a lytic lesion that is considered measurable. Blastic-only bone lesions are not allowed.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
- Adequate organ and bone marrow function within 28 days before enrollment. For all parameters listed below, the most recent results available must be used:
- Hemoglobin ≥ 9 g/dL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment.
- Absolute neutrophil count (ANC) ≥ 1500/mm\^3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.
- Platelet count ≥ 100,000/mm\^3. Note: Platelet transfusion is not allowed within 1 week prior to registration.
- Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \< 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastasis at baseline.
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 ×ULN or \< 5 × ULN in patients with liver metastasis.
- Serum albumin ≥ 2.5 g/dL.
- Creatinine clearance (CrCl) ≥ 30 mL/min (calculated using the Cockcroft and Gault equation). Cockcroft-Gault equation: CrCl (mL/min) = [140 - age (years)] × weight (kg) 72 × serum creatinine (mg/dL) {× 0.85 for females}
- International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- Adequate treatment washout period before randomization, defined as:
- Major surgery: ≥ 3 weeks
- Radiation therapy including palliative and/or stereotactic radiation therapy ≥ 2 weeks
- Hormonal therapy: ≥ 2 weeks
- Targeted therapy (CDK4/6i, PARP inhibitor, AKTinhibitor, mTOR inhibitor, PIK3CA inhibitor): ≥ 2 weeks
- Immunotherapy (non-antibody-based therapy): ≥ 2 weeks
- T-DXd: ≥ 3 weeks
- Evidence of post-menopausal status or for individuals of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at screening or baseline. Individuals of childbearing potential are...
- Individuals of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least one highly effective method of contraception from the time of registration through final study...
- Non-sterilized male patients who are sexually active with a partner of childbearing potential must agree to use a condom with spermicide from registration and throughout duration of the study treatment. The following...
- Abstinence (not having sexual relations with a person who can get you pregnant)
- Non-hormonal Intrauterine Device (IUD)
- Vasectomy
- Sterilization
- Bilateral tubal occlusion
What rules you out
- Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.
- Patients with brain metastases (BM) except for asymptomatic treated BM not requiring ongoing corticosteroid treatment with stable lesions on baseline/screening brain MRI. Patients who require treatment of brain...
- Active serious infection requiring ongoing antibiotics.
- History of an anaphylactic reaction to irinotecan.
- Pregnant or breastfeeding.
- Ongoing treatment with another investigational drug or other treatment trial.
- Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Any other condition that may put a participant at higher risk, at the discretion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, 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 Los Angeles, California, United States; Miami, Florida, United States; Atlanta, Georgia, 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.