Comparing two chemotherapy regimens for HER2-positive early 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 clinical trial aims to compare the efficacy and safety of two chemotherapy regimens, TCbHP and EC-THP, in women with HER2-positive early breast cancer. It is a randomized controlled study that will evaluate how well these treatments work in optimizing adjuvant chemotherapy for this patient population. Participants will receive either regimen after surgical resection of their tumors, and their responses will be monitored to determine which approach is more effective.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women aged 18-70；
* 0-1 for ECOG；
* Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
* No gross or microscopic tumor remains after surgical resection；
* Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
* Postoperative pathological stage pT1-4N1-3M0；
* Did not receive neoadjuvant chemotherapy in the past；
* The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
* No peripheral neuropathy；
* Good postoperative recovery, at least 1 week interval between operation；
* The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
* Contraception during treatment for women of reproductive age；
* Cardiac function: LVEF\>50% for ultrasound examination；
* The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。

Exclusion Criteria:

* Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
* Have received chemotherapy for advanced disease；
* Transfer of any part；
* If any tumor \>T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
* Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
* Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
* Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
* The patient has been enrolled in other clinical trials；
* Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
* LVEF\<50% (cardiac ultrasound)；
* Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
* Known allergy to related drugs；
* Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
* Pregnant and lactating women；
* Those who tested positive for pregnancy before taking the drug after joining the trial；
* Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
* Persons without personal freedom and independent capacity for civil conduct。

Where it's running

• Fudan University Shanghai Cancer Center Shanghai, China, 200032
  Shanghai, Shanghai Municipality, China Recruiting

Similar studies

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

• Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy

  This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07340398

• Neoadjuvant therapy for HER2-positive early breast cancer

  This study is testing if a new drug called trastuzumab-deruxtecan can work better than standard chemotherapy for people with early HER2-positive breast cancer to see if it helps them respond better to treatment.

  Recruiting at 40 sites Phase 2 Women's Cancer Study Group GmbH · Baden-Baden, Baden-Wurttemberg and 43 other locations · NCT05704829

• Neoadjuvant therapy guided by drug screening for HER2 positive early breast cancer

  This study is testing if certain patients with early HER2-positive breast cancer can skip chemotherapy by using drug screening to find out which treatments work best for them.

  Recruiting Phase 1/2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT04750122

• Optimizing neoadjuvant treatment for HER2‑positive early breast cancer

  This trial will test whether using a new biomarker called HARPS to guide pre-surgery HER2-targeted therapy (trastuzumab and pertuzumab, with chemotherapy added when needed) improves treatment response for people with HER2‑positive early breast cancer.

  Recruiting at 7 sites Phase 2 Rutgers, The State University of New Jersey · Elizabeth, New Jersey and 6 other locations · NCT07402473

• Adjunct Therapy De-escalation in Early HER2+ and TNBC After Neoadjuvant Response

  This phase 2 trial tests stopping certain post-surgery immunotherapy and targeted therapies early in people with early HER2+ or triple-negative breast cancer who have no detectable cancer DNA after neoadjuvant treatment and surgery.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07407920

• Personalized coaching to help manage therapy for early breast cancer

  This trial tests whether typology-based coaching helps people with HR+/HER2- early breast cancer stay on ribociclib plus an aromatase inhibitor longer than standard education alone.

  Recruiting at 3 sites Institut fuer Frauengesundheit · Augsburg, Bavaria and 2 other locations · NCT07708571

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.