Evaluating a new treatment approach for operable HER2-positive 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 study aims to assess the effectiveness of a pre-operative treatment regimen combining pertuzumab and trastuzumab with chemotherapy in patients with HER2-positive breast cancer. It will investigate the correlation between early changes in various biomarkers and the likelihood of achieving a pathological complete response (pCR) after treatment. The study will utilize advanced imaging techniques and genomic testing to evaluate treatment response in approximately 94 patients. Participants will receive the treatment followed by surgery and continue with a year of adjuvant therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female or male, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
2. Primary tumor greater than (\>) 2 cm in diameter.
3. Age ≥ 18 years and \< 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
6. Availability of tumor tissue specimen after surgery.
7. Participants agree to undergo a core needle biopsy for genomic testing and organoid drug sensitivity assay.
8. Histologically proven diagnosis of breast cancer.
9. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
10. Had hormonal receptors (ER and PgR) assessed.
11. Signed informed consent.
12. Able to comply with the protocol.

Exclusion Criteria:

1. Metastatic disease (Stage IV) or bilateral breast cancer.
2. Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer.
3. Prior breast or non-breast malignancy within 5 years prior to study entry.
4. Inadequate bone marrow, renal, or liver function
5. History or evidence of cardiovascular condition
6. Severe, uncontrolled systemic disease
7. Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications.
8. Pregnancy or breast-feeding women.
9. Participants who received any investigational treatment within 4 weeks of study start.
10. Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.
11. Current chronic daily treatment with corticosteroids (dose \>10 mg methylprednisolone or equivalent \[excluding inhaled steroids\]).
12. Known hypersensitivity to any of the study drugs or excipients

Where it's running

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

Study contacts

• Study coordinator: Jiong Wu, MD
• Email: wujiong1122@vip.sina.com
• Phone: +862164175590

Similar studies

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

• BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer

  A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07518173

• IBI354 with or without pertuzumab versus taxane plus trastuzumab and pertuzumab for HER2-positive metastatic breast cancer

  This trial tests whether IBI354, with or without pertuzumab, works better than standard taxane plus trastuzumab and pertuzumab as first-line treatment for adults with HER2-positive unresectable locally advanced or metastatic breast cancer.

  Recruiting Phase 3 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Beijing, Beijing Municipality · NCT07377643

• Vaccine targeting HER2 in locally advanced breast cancer

  This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT06949410

• Neoadjuvant therapy for low-risk HER2-positive breast cancer patients

  This study is testing a new treatment plan for people with low-risk HER2-positive breast cancer to see if combining certain chemotherapy drugs with targeted therapy can work just as well with less intense treatment.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT06722599

• Treatment for hormone receptor positive HER2 positive breast cancer after neoadjuvant therapy

  This study is testing if combining two drugs, trastuzumab and nelatinib, can help people with hormone receptor positive HER2 positive breast cancer who still have cancer after initial treatment feel better compared to the usual combination of trastuzumab and pertuzumab.

  Recruiting Phase 3 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou · NCT05760612

• HER2-targeted vaccine combined with standard chemotherapy for breast cancer

  This study is testing if adding a new vaccine to standard chemotherapy can help people with HER2-positive breast cancer have better treatment results.

  Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT05325632

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.