Can a second ADC tame breast cancer after the first fails?
NCT ID NCT06649331
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study tests whether giving a different antibody-drug conjugate (ADC) to people with advanced breast cancer who have already tried an ADC can still shrink tumors or slow the disease. About 160 participants will receive one of several ADCs or a targeted pill. The goal is to see if rechallenging with a new ADC is safe and effective enough to control the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antibody-drug conjugates (SHR-A1811, SHR-A1921, SHR-A2009, SHR-A2102) and famitinib
- What this could lead to
- If successful, this could show that switching to a different ADC after one stops working is a viable strategy to control metastatic breast cancer.
- What could go wrong
- This is a small, early-phase trial with no control group, so results may not confirm effectiveness. ADCs can cause serious side effects like low blood counts or nerve damage.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2024
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: 1. Age ≥18 years; 2. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer; 3. Previously received ADCs; 4. The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2. Participants with any hormone receptor (HR) status will be allowed on study. 5. Prior endocrine therapy: Participants with HR-positive breast cancer must have received prior CDK4/6 inhibitor; 6. Participants must have measurable disease per RECIST 1.1. 7. The functions of the main organs are basically normal and meet the following conditions: I. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 10\^9 / L; PLT acuity 75 x 10\^9 / L; II. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); III. LVEF≥50% 8. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity; Participants may have discontinued all CDK4/6 inhibitor at least 14 days prior to study treatment initiation. Prior endocrine therapy does not require washout. 9. ECOG score ≤2, and life expectancy ≥3 months; 10. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug; 11. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: 1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis); 2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol); 3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months; 4. Presence of the third space effusion (such as massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods; 5. Participants with who had used immunosuppressive agents or systemic corticosteroids within 2 weeks before the first dose (dose\> 10mg/day prednisone or other corticosteroids at the physiological dose of the drug), excluding nasal spray or inhaled corticosteroids; 6. Presence of any active autoimmune disease or a history of autoimmune disease with potential relapse; 7. Known human immunodeficiency virus (HIV) infection that is not well controlled; 8. Known active hepatitis B (HBV DNA≥2000 IU/mL or 104 copies/mL) and hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower detection limit of the assay); 9. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes; 10. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment; 11. Pregnant or lactating patients; 12. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years; 13. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications; 14. Serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results 15. Deemed by the investigator to be ineligible for participation in the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Breast cancer institute of Fudan University Cancer Hospital
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Two-Drug HER2 attack vs one: which First-Line strategy helps advanced breast cancer patients live longer?