Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well sacituzumab govitecan (SG) works after treatment with trastuzumab deruxtecan (T-DXd). It is for adults with advanced breast cancer that uses hormones to grow and has low or very low levels of a protein called HER2. SG will be given at its approved dose and schedule.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, sign a consent form, and agree to study visits and procedures.
- Have hormone receptor-positive breast cancer with low or very low HER2 levels. The cancer must have spread or be advanced and unable to be removed by surgery.
- Have cancer that no longer responds to hormone treatment, and have received a CDK4/6 inhibitor, a drug that slows cancer growth.
- Have received 1 to 4 chemotherapy treatment plans for cancer that has spread. Prior antibody-drug treatments count toward this limit.
- Have received T-DXd and stopped because the cancer grew or side effects were too hard to tolerate. Cancer must have worsened after the latest treatment, unless that treatment was T-DXd stopped for side effects.
- Have cancer that can be measured on scans, be able to do self-care, and have blood tests showing good enough organ and bone marrow function.
- Wait the required time after earlier treatments: at least 3 weeks after major surgery or T-DXd, and at least 2 weeks after the other listed cancer treatments.
- If able to become pregnant, have a negative blood pregnancy test. Follow the study’s birth control rules if they apply to you.
Who can't join
- Have stage IIIc breast cancer that could still be treated with the goal of a cure.
- Have cancer in the brain unless it has been treated, is stable, causes no symptoms, and needs no ongoing steroid treatment. After brain surgery or radiation, wait at least 14 days.
- Have a serious active infection that needs ongoing antibiotics.
- Have had a severe allergic reaction called anaphylaxis to irinotecan.
- Be pregnant or breastfeeding.
- Be receiving another experimental drug or taking part in another trial that gives treatment or another intervention.
- Have a medical or mental health condition that could affect study results or prevent you from finishing study visits and tests.
- Have another condition that the study doctor believes could make participation too risky.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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+ (ISH- or untested)) and HER2 ULTRA LOW is defined as: IHC0+ (faint membrane staining up to 10%) * 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 primary tumor. * 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, acapivasertib or inavolisib). * 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: 1. Hemoglobin ≥ 9 g/dL. Note: Red blood cell transfusion is not allowed within 1 week prior to screening assessment. 2. 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. 3. Platelet count ≥ 100,000/mm\^3. Note: Platelet transfusion is not allowed within 1 week prior to registration. 4. 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. 5. Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 ×ULN or \< 5 × ULN in patients with liver metastasis. 6. Serum albumin ≥ 2.5 g/dL. 7. 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} 8. 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: 1. Major surgery: ≥ 3 weeks 2. Radiation therapy including palliative and/or stereotactic radiation therapy ≥ 2 weeks 3. Hormonal therapy: ≥ 2 weeks 4. Targeted therapy (CDK4/6i, PARP inhibitor, AKTinhibitor, mTOR inhibitor, PIK3CA inhibitor): ≥ 2 weeks 5. Immunotherapy (non-antibody-based therapy): ≥ 2 weeks 6. 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 defined as those who are not surgically sterile (i.e., underwent bilateral tubal occlusion, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. * 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 treatment. Not all methods of contraception are highly effective. * 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 are acceptable measures to prevent pregnancy: * Abstinence (not having sexual relations with a person who can get you pregnant) * Non-hormonal Intrauterine Device (IUD) * Vasectomy * Sterilization * Bilateral tubal occlusion Exclusion Criteria: * 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 metastases are eligible after 14 days post receipt of surgery or radiation, if felt to be clinically stable and not requiring ongoing corticosteroid treatment. * Active serious infection requiring ongoing antibiotics. * History of an anaphylactic reaction to irinotecan. * Pregnant or breastfeeding. * Ongoing treatment with another investigational drug or other interventional 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.
Study sites (3)
FL
- Baptist Health Herbert Wertheim Cancer Institute · Miami, FL 33176Reshma L Mahtani, D.O. · Study contact · (786) 596-2000 · rmahtani@baptisthealth.netKrystal Fernandez · Study contact · (786) 596-2000 · krystal.fernandez@baptisthealth.netMore trials in Miami
GA
- Winship Cancer Institute at Emory University · Atlanta, GA 30322Kevin Kalinsky, M.D., M.S. · Study contact · (404) 778-0519 · kkalins@emory.eduMore trials in Atlanta
KS
- University of Kansas Medical Center · Fairway, KS 66205Ryan Rader, M.D. · Study contact · rrader3@kumc.eduMore trials in Fairway