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

Breast Cancer Clinical Trial

— SOBER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03367676
• Other study ID #: RJBC1712
• Status: Recruiting
• Phase: Phase 2
• Start date: December 30, 2017
• Est. completion date: June 1, 2021

Study information

• Verified date: March 2020
• Source: Ruijin Hospital
• Contact: Jiayi Wu, doctor
• Phone: 8621-64370045
• Email: pinkscorpio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Trastuzumab
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.
• Docetaxel
Docetaxel 100mg/m2,d1,iv,q3w*4

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	Estimated percentage of patients alive and disease-free at 3 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: 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.	3-year estimates
Secondary	Breast Cancer Specific Survival	Estimated percentage of patients alive and disease-free at 3 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.	3-year estimates
Secondary	Overall Survival	Estimated percentage of patients alive and disease-free at 3 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.	3-year estimats
Secondary	Treatment-related adverse events	Incidence and severity of adverse events as assessed by NCI CTCAE V4.0	up to 4 months
Secondary	Change of LVEF after treatment	The change of LVEF after 12 weeks treatment compared to the baseline LVEF	up to 4 months