Clinical trial · Interventional
12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)
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
NCT03367676CI-TRIAL-00125382SOBERterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Why stopped (as posted): Due to slower than anticipated enrollment, the study was terminated early after 78 patients were recruited.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 12 weeks adjuvant docetaxel plus trastuzumab
- interventionNames
- Drug: Trastuzumab
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Disease-free Survival
- timeFrame
- 3-year estimates
- description
- 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.
Secondary outcomes (4)
- measure
- Breast Cancer Specific Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 \-
References
Publications (0)
Data not yet available
No reference posted for this study.