Breast CancerPhase 2SERIESNCT06263543
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
A Phase 2 study testing Sacituzumab govitecan in people with Breast Cancer and Metastatic Breast Cancer, run by Reshma L. Mahtani, D.O. at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Sacituzumab govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jun 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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+ (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).
Show all 37Show fewer
- 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 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
Kevin Kalinsky, M.D., M.S., (404) 778-0519, kkalins@emory.edu
- Recruiting
University of Kansas Medical Center
Fairway, Kansas, 66205
Ryan Rader, M.D., rrader3@kumc.edu
- Recruiting
Baptist Health Herbert Wertheim Cancer Institute
Miami, Florida, 33176
Reshma L Mahtani, D.O., (786) 596-2000, rmahtani@baptisthealth.net
Krystal Fernandez, (786) 596-2000, krystal.fernandez@baptisthealth.net
About this study
Official title: SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer
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.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Low Breast Cancer
- Being tested
- Sacituzumab govitecan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Also called Trodelvy
IV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan (SG) Infusion | Experimental | SG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity. Receives: Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator.
Measured: 24 months
Secondary outcomes (8)
Clinical benefit rate (CBR)
CBR will be assessed using RECIST 1.1 and is defined as the percentage of participants who received at least one dose of SG and have achieved CR, PR, or stable disease (SD) as assessed by the local investigator.
Measured: 24 months
Progression-free survival (PFS)
PFS is defined as the duration of time from the date of first treatment until the date of the first radiological progressive disease (PD) per RECIST 1.1 or death from any cause, whichever comes first.
Measured: 30 months
Overall survival (OS)
OS is defined as the duration of time of first treatment until the date of death from any cause.
Measured: 30 months
Duration of response (DOR)
DOR is defined as the duration of time from the date of first response (CR or PR) until the date of the first radiological PD per RECIST 1.1 or death from any cause, whichever comes first.
Measured: 30 months
Global Quality of Life
Global Quality of Life is measured by European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in individuals with cancer. The items are related to how difficult activities of daily living are, how often treatment or cancer-related symptoms occur and how much they interfere in daily activities and relationships. Each item is scored on a scale of 1 (not at all) to 4 (very much). Higher scores indicate worse quality of life.
Measured: 24 months
Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percent of participants who experienced a treatment-related AE or SAE while on study.
Measured: 30 months
Laboratory and Vital Sign Abnormalities
Percent of participants who experienced a laboratory or vital sign abnormality that was considered clinically significant by the investigator while on study.
Measured: 30 months
Growth Factor Support
Percent of participants who required the use of growth factor support (administered at the discretion of the investigator) while on study.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start17 Jun 2024
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reshma L. Mahtani, D.O.
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor-investigator, Reshma L. Mahtani, D.O., Baptist Health South Florida
- Investigators
- Reshma L Mahtani, D.O., Principal investigator, Baptist Health Herbert Wertheim Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263543
- Sponsor's protocol ID
- 2023-MAH-001
- Acronym
- SERIES
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.
PubMed 32223649Schmid P, Cortés J, Marmé F, Rugo HS, Tolaney SM, Oliveira M, Loirat D, Jhaveri K, Yoon OK, Motwani M, Wang H, Delaney RJ, Bardia A. Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study. Annals of Oncology. 2022; 33(Suppl7): S635-636.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW/ULTRA LOW MetaStatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06263543
- Acronym / sponsor ID
- SERIES / 2023-MAH-001
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Low Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Reshma L. Mahtani, D.O.University, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan (SG) Infusion | Experimental | Drug: Sacituzumab govitecanSG will be administered on Days 1 and 8 of continuous 21-day cycles at 10 mg/kg via intravenous (IV) infusion until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab govitecanAlso: TrodelvyIV infusion of 10 mg/kg on Days 1 and 8 of each continuous and consecutive 21-day cycles. The first infusion will last approximately 3 hours and subsequent infusions will last 1-2 hours if prior infusions were well tolerated. | Drug | Sacituzumab Govitecan (SG) Infusion |
Primary outcome
Overall response rate (ORR)
Time frame: 24 months
ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator.
8 secondary outcomes
Clinical benefit rate (CBR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 30 months
Overall survival (OS)
Time frame: 30 months
Duration of response (DOR)
Time frame: 30 months
Global Quality of Life
Time frame: 24 months
Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 30 months
Laboratory and Vital Sign Abnormalities
Time frame: 30 months
Growth Factor Support
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 32223649Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.
- BackgroundSchmid P, Cortés J, Marmé F, Rugo HS, Tolaney SM, Oliveira M, Loirat D, Jhaveri K, Yoon OK, Motwani M, Wang H, Delaney RJ, Bardia A. Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study. Annals of Oncology. 2022; 33(Suppl7): S635-636.
- Baptist Health Herbert Wertheim Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reshma L Mahtani, D.O. principal investigator
Baptist Health Herbert Wertheim Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan in people with Breast Cancer and Metastatic Breast Cancer, run by Reshma L. Mahtani, D.O. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reshma L Mahtani, D.O. ((786) 596-2000, rmahtani@baptisthealth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263543, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.