Can a shorter treatment hold off small HER2-Positive breast cancers?
NCT ID NCT03367676
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a 12-week course of docetaxel plus trastuzumab after surgery can keep small (≤1 cm), node-negative HER2-positive breast cancer from returning. Women who have completed radical surgery for this type of cancer receive the two drugs every three weeks for four cycles. Researchers will track how many participants remain alive and disease-free three years later, along with overall survival and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Trastuzumab and docetaxel
- What this could lead to
- If successful, this could support a shorter, less intensive adjuvant regimen for early-stage HER2-positive breast cancer, potentially reducing treatment burden while maintaining disease control.
- What could go wrong
- This is a phase 2 trial with a modest number of participants, so results may not be definitive. The shorter regimen might be less effective than standard longer treatment, and side effects from chemotherapy and trastuzumab remain possible.
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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
-
78 people
The number who actually took part.
- Started
-
Dec 2017
- Finished
-
Oct 2025
- 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 years and older
- 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: Women aged ≥18 years Have finished radical operation Pathologically confirmed dignosis of infiltrating primary breast cancer According to AJCC ,pT≤1cm, pN0,no evidence for metastasis Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ ) Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time \> 12 months Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function. Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study. Written informed consent according to the local ethics committee requirements. Exclusion Criteria: pT\>1cm or node positive Metastatic breast cancer Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease Has symptomatic peripheral neuropathy \> grade 2 according to NCI Known severe allergy to any drugs in this study Has cadiac Dysfunction or lung dysfunction defined as follows: 1. grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II 2. angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms 3. uncontrolled high-risk arryhthmia 4. unconrolled hypertension Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive Patient is pregnant or breast feeding \-
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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
-
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a newer drug ease the bone pain of chemotherapy support?