New pill combo aims to prevent return of early breast cancer

NCT ID NCT04296162

Completed Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether taking oral chemotherapy pills (vinorelbine or capecitabine) along with the targeted drug trastuzumab can help prevent breast cancer from coming back in women with small, HER2-positive tumors that have not spread to lymph nodes. The 182 participants took the combination after surgery. The goal was to see how long they stayed cancer-free, with a focus on safety and convenience of oral treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: oral vinorelbine or capecitabine combined with trastuzumab
What this could lead to: If successful, this could offer a more convenient oral chemotherapy option alongside targeted therapy for early-stage HER2-positive breast cancer, potentially reducing recurrence risk.
What could go wrong: This is a Phase II trial with only 182 participants, so results are preliminary. The combination may not improve outcomes over standard care, and side effects from chemotherapy and trastuzumab (e.g., heart issues, fatigue) remain concerns.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

Locations

Zhi-Ming Shao

Shanghai, 200032, China

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