Breast CancerPhase 2SOBERNCT03367676
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
A Phase 2 study testing Trastuzumab and Docetaxel in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2017to 1 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- Known severe allergy to any drugs in this study
- Has cadiac Dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
- angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arryhthmia
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Tumors ≤1cm, Node-negative, HER2-positive Breast cancER (SOBER):a Single-grouparm, Open-label, Prospective, Phase 2 Study
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Read the detailed description
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab, Docetaxel
- Keywords
- trastuzumab, adjuvant therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.
DocetaxelDrug
Docetaxel 100mg/m2，d1，iv，q3w*4
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 12 weeks adjuvant docetaxel plus trastuzumab Receives: Drug: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Measured: 3-year estimates
Secondary outcomes (4)
Breast Cancer Specific Survival
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive.
Measured: 3-year estimates
Overall Survival
Defined as the time from the date of surgery to death from any cause; or censored at date last known alive.
Measured: 3-year estimats
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
Measured: up to 4 months
Change of LVEF after treatment
The change of LVEF after 12 weeks treatment compared to the baseline LVEF
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start30 Dec 2017
- Primary completion1 Jul 2024
- Study completion1 Oct 2025
Why it stopped: Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhu, Ruijin Hospital
- Investigators
- Li Zhu, doctor, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367676
- Sponsor's protocol ID
- RJBC1712
- Acronym
- SOBER
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2017
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Tumors ≤1cm, Node-negative, HER2-positive Breast cancER (SOBER):a Single-grouparm, Open-label, Prospective, Phase 2 Study
- ClinicalTrials.gov ID
- NCT03367676
- Acronym / sponsor ID
- SOBER / RJBC1712
- Conditions
- Breast Cancer
- Keywords
- trastuzumab, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited.
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Dec 2017 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Detailed description
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Trastuzumab, Drug: Docetaxel12 weeks adjuvant docetaxel plus trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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+ )
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabTrastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles. | Drug | Experimental Arm |
| DocetaxelDocetaxel 100mg/m2，d1，iv，q3w*4 | Drug | Experimental Arm |
Primary outcome
Disease-free Survival
Time frame: 3-year estimates
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
4 secondary outcomes
Breast Cancer Specific Survival
Time frame: 3-year estimates
Overall Survival
Time frame: 3-year estimats
Treatment-related adverse events
Time frame: up to 4 months
Change of LVEF after treatment
Time frame: up to 4 months
Results and safety
The study was stopped early (reason given: Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhu, doctor principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab and Docetaxel in people with Breast Cancer, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: 3-year estimates). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.