12 weekS Adjuvant dOcetaxel Plus trastuzumaB in Patients With Small, Node-negative, HER2-positive Breast cancER (SOBER)

NCT ID: NCT03367676

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2021-06-01

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

12 weeks adjuvant docetaxel plus trastuzumab

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.

Docetaxel

Intervention Type: DRUG

Docetaxel 100mg/m2，d1，iv，q3w\*4

Interventions

Trastuzumab

Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.

Intervention Type: DRUG

Docetaxel

Docetaxel 100mg/m2，d1，iv，q3w\*4

Intervention Type: DRUG

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Zhu, doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayi Wu, doctor

Role: CONTACT

pinkscorpio@163.com

8621-64370045 ext. 602268

Facility Contacts

Shuning Ding, doctor

Role: primary

nannanyard@163.com

64370045 ext. 602215

Other Identifiers

RJBC1712

Identifier Type: -

Identifier Source: org_study_id