Treatment adjustment for HER2 positive breast cancer after initial therapy

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 Phase II unicentric randomized trial focuses on patients with early HER2 positive breast cancer who are candidates for neoadjuvant therapy using trastuzumab and pertuzumab. Blood samples will be collected to analyze circulating tumor cells (CTCs) for HER2 positivity before treatment. Patients who achieve a pathological complete response will be randomized into two groups: one receiving adjuvant trastuzumab alone and the other receiving trastuzumab plus pertuzumab, based on the presence or absence of HER2 positive CTCs. The study aims to evaluate the effectiveness of treatment de-escalation based on CTC analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* HER2 positive breast cancer (hormone receptors positive or negative)
* Stage I to III
* Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
* Breast surgery after neoadjuvant therapy
* Preserved coagnition
* ECOG 0-3
* For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)
* Agreement on participation and signature of de ICF

Exclusion Criteria:

* Contradindication for trastuzumab or pertuzumab
* Adjuvant chemotherapy. Hormone therapy is allowed
* Second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer

Where it's running

• A.C. Camargo Cancer Center
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Marcelle G Cesca, MD — A.C. Camargo Cancer Center
• Study coordinator: Marcelle G Cesca, MD
• Email: marcelle.cesca@accamargo.org.br
• Phone: +551121895000

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.