New pill combo aims to prevent return of early breast cancer
NCT ID NCT04296162
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
182 people
The number who actually took part.
- Started
-
Mar 2020
- Finished
-
Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. women aged 18-70 years old; 2. T ≤1cm and negative lymph node confirmed by histopathology after early breast cancer surgery 3. HER2 positive confirmed by histopathology after early breast cancer surgery(HER2-positive breast cancer defined as a positive in situ hybridization test or an Immunohistochemistry (IHC) status of 3+. If IHC is 2+, a negative in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) , or Silver in situ hybridization (SISH)) test is required by local laboratory testing.) 4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 5. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN,and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula). 6. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: 1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy); 2. Has bilateral breast cancer; 3. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. 4. Has metastic (Stage 4) breast cancer; 5. Is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; 6. Patients participating in other clinical trials at the same time; 7. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; 8. Has severe or uncontrolled infection; 9. Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; 10. the researchers judged patients to be unsuitable for the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhi-Ming Shao
Shanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?