Comparing Docetaxel and Trastuzumab to Paclitaxel and Trastuzumab for Early HER2-positive Breast Cancer

A Single-center, Prospective, Randomized Study of Adjuvant Paclitaxel and Trastuzumab Versus Docetaxel and Trastuzumab in Stage I HER2 Positive Breast Cancer

This study is testing if a new treatment combining docetaxel and trastuzumab is better than the standard treatment of paclitaxel and trastuzumab for women with early HER2-positive breast cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: trastuzumab, chemotherapy, cyclophosphamide
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05189067 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a new treatment regimen combining docetaxel and trastuzumab administered every three weeks for four cycles, compared to the standard weekly regimen of paclitaxel and trastuzumab for twelve weeks in women with stage I HER2-positive breast cancer. The study is a prospective, randomized, open-label trial conducted at a single center in China. It focuses on patients with tumors measuring up to 2 cm and negative axillary lymph nodes or micrometastasis, assessing outcomes such as disease-free survival and overall survival.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 70 with histopathologically confirmed invasive HER2-positive breast cancer and specific tumor characteristics.

Not a fit: Patients with advanced HER2-positive breast cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more convenient and potentially equally effective treatment option for patients with early-stage HER2-positive breast cancer.

How similar studies have performed: Previous studies have shown success with trastuzumab in combination with chemotherapy, indicating that this approach has a solid foundation, although the specific comparison of docetaxel with paclitaxel in this context is novel.

Eligibility criteria

Inclusion Criteria:

1. Female aged 18 - 70 years old;
2. The histopathological confirm of invasive breast cancer;
3. HER-2 positive: immuno-histochemistry (IHC) 3+ or fluorescence in situ hybridization (FISH) confirmed amplification of erbb2 gene;
4. Tumor must be ≤ 2cm in greatest dimension, negative axillary lymph node or with micrometastasis (axillary nodes with tumor clusters ≤ 0.2cm);
5. No more than 90 days from the patient's most recent breast surgery for this breast cancer;
6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
7. Adequate bone marrow function: neutrophil ≥ 1500/mm\^3, hemoglobin ≥ 9 g/dl, and platelets ≥ 100,000/mm\^3;
8. Adequate liver and renal function: creatinine ≤ 1.5 folds of the upper limit of normal value; aspartate aminotransferase and alanine aminotransferase ≤ 1.5 folds of the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2 folds of the upper limit of normal value for patient with Gilbert 's syndrome;
9. Left ventricular ejection fraction (LVEF) ≥ 50%;
10. Willing and able to sign informed consent.

Exclusion Criteria:

1. Any of the following due to teratogenic potential of chemotherapy: pregnant women, nursing women, women of childbearing potential who are unwilling to employ adequate contraception;
2. Locally advanced tumors at diagnosis, including tumors fixed to the chest wall, peau d'orange, skin ulcerations/nodules, or clinical inflammatory changes;
3. History of prior chemotherapy in the past 5 years;
4. History of prior trastuzumab therapy;
5. Patients with a history of previous invasive breast cancer;
6. Active, unresolved infection;
7. Prior history of any other malignancy in the past 5 years, except for early stage tumors of the skin or cervix treated with curative intent;
8. Can not tolerate or be allergic to chemotherapy, anti-HER-2 therapy or pharmaceutical materials such as benzyl alcohol;
9. ≥ grade 2 neuropathy;
10. Active cardiac disease: Any prior myocardial infarction (asymptomatic changes on EKG suggestive of old myocardial infarction is not an exclusion); Documented congestive heart failure (CHF); Current use of any therapy specifically for CHF; Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg); Clinically significant pericardial effusion;
11. The antibody of hepatitis C virus, HIV or Treponema pallidum positive; HBsAg positive and hepatitis B virus DNA in peripheral blood ≥ 10\^3 copy/mL；
12. Enrollment on other Investigational studies within 30 days;
13. Not allowed by the investigators.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Tao Pan — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Tao Pan

Conditions HER2-positive Breast Cancer; Adjuvant Therapy; Docetaxel; Paclitaxel