Can a Two-Drug attack shrink Hard-to-Treat breast cancer?
NCT ID NCT07757230
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This phase II trial is testing whether combining an experimental antibody called SSGJ-612 with a targeted chemotherapy (an antibody-drug conjugate) can shrink tumors in people with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer. The study enrolls about 87 participants whose cancer has spread and who have not previously tested positive for HER2. The main goal is to see how many patients experience tumor shrinkage, while also monitoring side effects and how long the benefit lasts.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SSGJ-612 (an experimental HER2-targeted antibody) combined with a HER2-targeted antibody-drug conjugate (ADC)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with HR-positive, HER2-low or ultralow metastatic breast cancer, potentially improving tumor shrinkage and delaying progression.
- What could go wrong
- This is a phase II trial with a modest number of participants, so results may not hold up in larger studies. The combination may cause side effects, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 87 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Voluntary participation in this study, signed informed consent form, good treatment compliance, and willingness to cooperate to complete all trial procedures. * Expected survival duration ≥ 3 months. * Histopathologically confirmed breast cancer meeting all of the following criteria simultaneously: 1. Metastatic tumor; 2. Tumor samples tested by central laboratory confirmed as HER2-low or HER2 ultra-low expression; 3. No prior test results reporting HER2 positivity; 4. Tumor sample testing confirms hormone receptor-positive (HR+) status. * Patients must satisfy either of the following conditions: 1. Disease progression within 6 months after initiation of first-line endocrine therapy combined with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors for metastatic disease; 2. Received at least 2 lines of prior endocrine therapy for metastatic disease, with disease progression post-treatment. * Participants in Part 1: Breast cancer patients who have received at least one line of chemotherapy for metastatic disease; Participants in Part 2: Breast cancer patients who have not received any chemotherapy for metastatic disease. * At least one repeatedly and accurately measurable tumor lesion as target lesion assessed per RECIST v1.1 criteria. Exclusion Criteria: * Uncontrolled or severe cardiovascular disease. * History of interstitial lung disease (ILD)/pneumonia requiring corticosteroid therapy (non-infectious), or current ILD/pneumonia, or suspected ILD/pneumonia not excluded by screening imaging. * Presence of pulmonary-specific, clinically significant comorbid conditions. * Presence of spinal cord compression, or clinically active central nervous system metastases. * Female patients who are pregnant, breastfeeding, or planning pregnancy. * Patients who received investigational drug therapy in another clinical trial within 30 days prior to first study drug administration, or who are concurrently enrolled in another clinical trial. Note: Exclusions include participation in observational (non-interventional) clinical trials, or being in the follow-up phase of an interventional clinical trial. * Presence of drug abuse, or other diseases (e.g., psychiatric disorders) that, in the investigator's judgment, may interfere with patient participation in the trial or affect the assessment of trial outcomes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood test reveal when breast cancer treatment stops working?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Zapping a few growing tumors may keep breast cancer drugs working longer
- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?
- Can a platform trial match the right drug combo to each tumor?
- Can a vaccine teach the immune system to fight HER2-Positive tumors?