Invasive Breast CancerPhase 2NeoSTARNCT04230109
Sacituzumab Govitecan In TNBC
A Phase 2 study testing Sacituzumab Govitecan and Pembrolizumab in people with Invasive Breast Cancer and Triple Negative Breast Cancer, run by Massachusetts General Hospital at 5 sites in United States.
Trial summary
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: Sacituzumab govitecan (SG) Pembrolizumab (combination therapy with SG) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Breast Cancer, Triple Negative Breast Cancer, ER-Negative Breast Cancer
- What is being tested?
- Sacituzumab Govitecan and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Jul 2020to Oct 2029
- 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
- Female or male patients ≥ 18 years of age.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated.
- Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to use effective contraceptive measures that have a failure rate of less than 1% per year from the initiation of treatment through at least 6 months b. after the last dose of study treatment. WOCBP must agree to 1 of the following contraceptive methods:
- Complete abstinence from intercourse of reproductive potential, or
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- Consistent and correct use of 1 of the following methods of birth control:
- Nonhormonal intrauterine device (IUD); Hormonal IUD in conjunction with a barrier method; Female sterilization (have had surgical bilateral oophorectomy with or; without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment; Vasectomy in the male partner (upon medical assessment of surgical success)
- Male patients with female partners of childbearing potential must practice
- Complete abstinence from intercourse of reproductive potential
- Have a surgically successful vasectomy upon medical assessment, or
- Use condoms plus partner use of a contraceptive method with a failure rate of <1% per year during treatment and until 3 months after last dose of study drug.
- ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.
- Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
- Absolute neutrophil count (ANC) ≥ 1,500 per mm3
- Platelets ≥ 100,000 per mm3
- Hemoglobin ≥9.0 g/dL
- PT-INR ≤1.5 x institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPPT is within therapeutic range of intended use of anticoagulants (for patients receiving pembrolizumab only).
- Serum creatinine <1.5 mg/dL or creatinine clearance ≥50 mL/min (via the Cockcroft-Gault formula) for participants with creatinine levels above institutional upper limit of normal (ULN)
- Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5 X ULN and serum albumin > 3 g/dL).
Who cannot join
- Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.)
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
- History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.
- History of cardiac failure, known cardiomyopathy (LVEF < 50%; new LVEF assessment is not specifically required for this trial), significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: ---Known risk to prolong the QT interval or induce Torsade's de Pointes.; Uncorrected hypomagnesemia or hypokalemia; Systolic Blood Pressure (SBP) >160 mmHg or <90 mmHg. Higher blood pressure is permissible per discretion of treating physician; Bradycardia (heart rate <50 at rest), by ECG or pulse; On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >470 screening ECG
- Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.
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- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to enrollment are eligible for this trial. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participants who are not good candidates for the study (as per investigator judgement)
- History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to sacituzumab govitecan.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 4 recruiting
- Active, not recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Sara Tolaney, MD, MPH, 617-632-3800
Sara Tolaney, MD, MPH
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Laura Spring, MD, 617-726-6500, LSPRING2@PARTNERS.ORG
Laura Spring, MD
- Recruiting
Massachusetts General Hospital - North Shore Cancer Center
Danvers, Massachusetts, 01923
Therese Mulvey, MD, 978-882-6060
Therese Mulvey, MD
- Recruiting
Massachusetts General Hospital at Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Amy Comander, MD, 617-219-1230
Amy Comander, MD
About this study
Official title: A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)
The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
Read the detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
This research study involves an experimental study treatment. The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open.
Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC).
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Eligible participants will receive Sacituzumab govitecan for up to 12 weeks.
- This can be followed by standard chemotherapy at the discretion of the treating physician.
- It is expected that about 50 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC.
Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading.
After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open.
- Conditions
- Invasive Breast Cancer, Triple Negative Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, HER2-negative Breast Cancer
- Being tested
- Sacituzumab Govitecan, Pembrolizumab
- Keywords
- Invasive Breast Cancer, Triple Negative Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, HER2-negative Breast Cancer
- Medical subject headings
- Triple Negative 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 IMMU-132
Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort)
PembrolizumabDrug
Pembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort)
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan (monotherapy cohort) | Experimental | - The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.
* This can be followed by standard chemotherapy at the discretion of treating physician. Receives: Drug: Sacituzumab Govitecan |
| Sacituzumab Govitecan and Pembrolizumab (combination cohort) | Experimental | - The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
* Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.
* Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles.
* This can be followed by standard chemotherapy at the discretion of treating physician. Receives: Drug: Sacituzumab Govitecan; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response(pCR) rate with sacituzumab govitecan
pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.
Measured: 12 Weeks
Secondary outcomes (5)
Disease-Free Survival
Kaplan-Meier methods and descriptive statistics
Measured: Time from the first dose of study treatment to disease recurrence/progression by RECIST v1.1 or death due to any cause, up to 36 months
Overall Survival
Kaplan-Meier methods and descriptive statistics
Measured: defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months
Change in Breast Conserving Surgery Rate (BCS) rate
RCB calculator: http:// RCB calculator: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Measured: 12 Weeks
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
CTCAE v5.0
Measured: Baseline to 12 weeks
Assessment of Quality of life (QOL)
EORTC questionnaire
Measured: Baseline up to 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start14 Jul 2020
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 239 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Laura M. Spring, MD, Massachusetts General Hospital
- Investigators
- Laura Spring, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230109
- Sponsor's protocol ID
- 19-578
- Acronym
- NeoSTAR
- Status last verified
- Jul 2026
- First submitted
- 13 Jan 2020
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Spring LM, Tolaney SM, Fell G, Bossuyt V, Abelman RO, Wu B, Maheswaran S, Trippa L, Comander A, Mulvey T, McLaughlin S, Ryan P, Ryan L, Abraham E, Rosenstock A, Garrido-Castro AC, Lynce F, Moy B, Isakoff SJ, Tung N, Mittendorf EA, Ellisen LW, Bardia A. Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial. Ann Oncol. 2024 Mar;35(3):293-301. doi: 10.1016/j.annonc.2023.11.018. Epub 2023 Dec 12.
PubMed 38092228
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)
- ClinicalTrials.gov ID
- NCT04230109
- Acronym / sponsor ID
- NeoSTAR / 19-578
- Conditions
- Invasive Breast Cancer, Triple Negative Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, HER2-negative Breast Cancer
- Keywords
- Invasive Breast Cancer, Triple Negative Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, HER2-negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 239 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 18 Jan 2020 (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.
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC)
The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
Detailed description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
This research study involves an experimental study treatment. The names of the study drugs involved in this study is:
- Sacituzumab govitecan (SG)
- Pembrolizumab (combination therapy with SG)
The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open.
Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC).
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
- Eligible participants will receive Sacituzumab govitecan for up to 12 weeks.
- This can be followed by standard chemotherapy at the discretion of the treating physician.
- It is expected that about 50 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC.
Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading.
After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan (monotherapy cohort) | Experimental | Drug: Sacituzumab Govitecan- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles. * This can be followed by standard chemotherapy at the discretion of treating physician. |
| Sacituzumab Govitecan and Pembrolizumab (combination cohort) | Experimental | Drug: Sacituzumab Govitecan, Drug: Pembrolizumab- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. * Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles. * Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles. * This can be followed by standard chemotherapy at the discretion of treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Female or male patients ≥ 18 years of age.
- Histologically confirmed diagnosis of invasive breast cancer, previously untreated.
- Pre-and postmenopausal women are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Male patients with female partners of childbearing potential must practice
- ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)
Key exclusion criteria (9 listed)
- Participants currently receiving systemic therapy for any malignancy or having received systemic therapy for a malignancy in the preceding 3 years. (Concurrent endocrine therapy allowed in the adjuvant setting. Concurrent GnRH agonists allowed in any setting. Concurrent CDK4/6 inhibitor not allowed in any setting.)
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
- Pregnant or breast-feeding women are excluded from this study because the safety of study medications is not established.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to enrollment are eligible for this trial. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
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: IMMU-132Sacituzumab Govitecan via iv, predetermined dosage per protocol, two days per 21-day cycle, for 4 cycles (monotherapy cohort) | Drug | Sacituzumab Govitecan (monotherapy cohort), Sacituzumab Govitecan and Pembrolizumab (combination cohort) |
| PembrolizumabPembrolizumab via iv, predetermined dosage per protocol, per 21-day cycle, for 4 cycles (combination cohort) | Drug | Sacituzumab Govitecan and Pembrolizumab (combination cohort) |
Primary outcome
Pathological complete response(pCR) rate with sacituzumab govitecan
Time frame: 12 Weeks
pCR is defined as no residual invasive carcinoma in the breast and in the lymph node. The two-sided 95% CIs for pCR rate will be calculated.
5 secondary outcomes
Disease-Free Survival
Time frame: Time from the first dose of study treatment to disease recurrence/progression by RECIST v1.1 or death due to any cause, up to 36 months
Overall Survival
Time frame: defined as the time from the first dose of study treatment to the date of death or last contact up to 36 months
Change in Breast Conserving Surgery Rate (BCS) rate
Time frame: 12 Weeks
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v5.0
Time frame: Baseline to 12 weeks
Assessment of Quality of life (QOL)
Time frame: Baseline up to 12 Weeks
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 17 Jul 2026.
- Derived from this study: PubMed 38092228Spring LM, Tolaney SM, Fell G, Bossuyt V, Abelman RO, Wu B, Maheswaran S, Trippa L, Comander A, Mulvey T, McLaughlin S, Ryan P, Ryan L, Abraham E, Rosenstock A, Garrido-Castro AC, Lynce F, Moy B, Isakoff SJ, Tung N, Mittendorf EA, Ellisen LW, Bardia A. Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial. Ann Oncol. 2024 Mar;35(3):293-301. doi: 10.1016/j.annonc.2023.11.018. Epub 2023 Dec 12.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Laura Spring, MD principal investigator
Massachusetts General Hospital
5 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 and Pembrolizumab in people with Invasive Breast Cancer and Triple Negative Breast Cancer, run by Massachusetts General Hospital at 5 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 21 inclusion and 9 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Laura Spring, MD (617-726-6500, LSPRING2@PARTNERS.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response(pCR) rate with sacituzumab govitecan (time frame: 12 Weeks). 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 NCT04230109, which also lists 1 linked publication.
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 17 Jul 2026.