Can a shorter treatment hold off small HER2-Positive breast cancers?

NCT ID NCT03367676

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

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

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