Using blood ctDNA changes to guide treatment for HER2‑negative metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an exploratory, multi‑stage Phase 2 study that gives all enrolled patients two cycles of an antibody‑drug conjugate (ivonescimab) with blood samples collected before Cycle 1 and before Cycle 2 to measure ctDNA variant allele frequency (VAF). In Stage 2, patients without radiographic progression are assigned to different treatment strategies based on the percentage reduction in mean ctDNA VAF after those two cycles. The protocol tests whether early ctDNA VAF dynamics can serve as a biomarker to trigger treatment intensification for patients showing inadequate ctDNA decline. Clinical outcomes and safety will be followed to determine if ctDNA‑guided decisions improve disease control compared with standard approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-75 years；ECOG performance status 0-1； Histologically or cytologically confirmed HER2-negative metastatic breast cancer； At least one measurable lesion per RECIST v1.1； Eligible for ADC therapy； Adequate organ and bone marrow function； Life expectancy ≥3 months； Willingness to provide tumor tissue and blood samples； Signed informed consent

Exclusion Criteria:

* Prior treatment with ADC targeting the same antigen and payload；History of grade ≥3 immune-related adverse events； Active or untreated CNS metastases； Active autoimmune disease requiring systemic therapy； Clinically significant cardiovascular disease； Active interstitial lung disease； Active infection including tuberculosis, HIV, hepatitis B or C； Pregnancy or breastfeeding；Investigator-determined conditions that may interfere with study participation

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Hongxia WANG
• Email: whx365@126.com
• Phone: 86-138196379

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using plasma ctDNA methylation to guide adjuvant chemotherapy for high-risk T3N0 colorectal cancer

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• Plasma ctDNA methylation-guided adjuvant chemotherapy for stage I / low-risk stage II colorectal cancer

  This trial will test whether using a blood test for ctDNA methylation one month after surgery to guide adjuvant chemotherapy (such as capecitabine) helps clear ctDNA and lower recurrence risk in adults with stage I or low-risk stage II colorectal cancer who are ctDNA-positive.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07562659

• Plasma ctDNA methylation-guided adjuvant chemotherapy for people with T4N0 and low‑risk stage III colorectal cancer.

  This trial will test whether using a blood test (plasma ctDNA methylation) to guide 3 vs 6 months of adjuvant chemotherapy or to switch regimens helps people with T4N0 or low‑risk stage III colorectal cancer after surgery.

  Recruiting Phase 2 Fudan University · Shanghai · NCT07562503

• Plasma ctDNA methylation–guided adjuvant chemotherapy for high-risk stage III colorectal cancer

  This trial will test whether adding bevacizumab to standard FOLFOX or CAPOX chemotherapy based on plasma ctDNA results helps adults with high-risk stage III colorectal cancer (T4N+ or T1-3N2).

  Recruiting Phase 2 Fudan University · Shanghai · NCT07562490

• TROP2‑PET and FDG‑PET to predict response to anti‑TROP2 antibody‑drug therapy in advanced HER2‑negative breast cancer

  See if combining a TROP2 PET scan with an FDG PET scan can predict who with advanced HER2‑negative breast cancer will respond to anti‑TROP2 antibody‑drug treatments.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT07471776

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.