Comparing two treatment regimens for HER2-positive breast cancer before surgery

Neoadjuvant TCHP Versus THP in Patients With Human Epidermal Growth Factor Receptor 2-positive Breast Cancer (neoCARHP) : a Randomized, Open-label, Multicenter, Phase III Trial

This study is testing two different treatment plans for people with HER2-positive breast cancer to see which one helps more patients have no cancer left before surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 774 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04858529 on ClinicalTrials.gov

What this trial studies

The neoCARHP study is a randomized, open-label, multicenter phase III trial designed to evaluate the efficacy and safety of two neoadjuvant treatment regimens, TCHP and THP, in patients with HER2-positive breast cancer. Participants will be randomly assigned to receive either TCHP or THP every three weeks prior to surgical intervention. The primary goal is to determine the percentage of patients achieving a pathological complete response (pCR), indicating no residual invasive cancer in the breast and lymph nodes after treatment.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with histologically confirmed invasive HER2-positive breast cancer at clinical stage II-IIIC.

Not a fit: Patients with hormone receptor-negative breast cancer or those with a left ventricular ejection fraction below 55% may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with HER2-positive breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar neoadjuvant approaches for HER2-positive breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* To take part in the trial, patients must be aged \> 18 years old and supply a signed informed consent form.

Patients must also have breast cancer meeting the following criteria:

* Histologically confirmed invasive breast carcinoma
* Clinical stage II-IIIC at presentation. HER2-positive breast cancer scored as 3+ by immunohistochemistry (IHC) in \> 10% of immunoreactive cells, or HER2 gene amplification (ratio of HER2 gene signals to centromere 17 signals ≥2.0) by in situ hybridization (ISH).

Known hormone receptor status (ER and PR). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. Completed all necessary baseline laboratory and radiologic examinations prior to randomization.

Baseline left ventricular ejection fraction (LVEF)≥55% measured by echocardiography (ECHO).

Women who are not postmenopausal (≥12 months of amenorrhea) or surgically sterile (absence of ovaries and/or the uterus) must agree to remain abstinent or to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception during the treatment period and for at least 6 months after the last dose of study treatment.

Clinical diagnosis of Alzheimer's Disease. Must be able to swallow tablets. All patients must be able to comply with the study protocol, according to the investigator's judgment.

Exclusion Criteria:

* Stage IV (metastatic) breast cancer Inflammatory breast cancer Previous anti-cancer therapy or radiotherapy for any malignancy. A history of other malignancies, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma.

Concurrent anti-cancer treatment in another clinical trial, including hormone therapy, bisphosphonate therapy, or immunotherapy.

Received a major non-breast cancer-related surgical procedure within the 4 weeks before randomization or from which the patient has not fully recovered.

A serious cardiac illness or medical condition, including but not limited to the following:

Documented history heart failure or systolic dysfunction (LVEF \< 50%). High-risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate \>100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block).

Angina pectoris requiring anti-angina medication. Clinically significant valvular heart disease. Evidence of transmural infarction on ECG Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness.

Any of the following abnormal laboratory tests immediately prior to randomization:

Total bilirubin \> 1.5 × upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin \> 2 × ULN Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.25 × ULN Alkaline phosphatase \> 2.5 × ULN Serum creatinine \> 1.5 × ULN Total white blood cell (WBC) count \< 2500 cells/uL Absolute neutrophil count \<1500 cells/uL Platelet count \<100,000 cells/uL Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol Pregnant or lactating: a negative serum pregnancy test is required for all women who are not postmenopausal (≥ 12 months of amenorrhea).

Insulin dependent diabetes. Thyroid disease.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Kun Wang, Phd

Conditions Neoadjuvant Therapies for HER2+ Breast Cancer