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

• ClinicalTrials.gov Identifier: NCT03367676
• Recruitment Status: Unknown
• First Posted: December 11, 2017
• Last Update Posted: March 10, 2020
• Sponsor: Ruijin Hospital
• Information provided by (Responsible Party): Li Zhu, Ruijin Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Trastuzumab; Drug: Docetaxel	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 112 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 30, 2017
• Estimated Primary Completion Date: January 1, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Arm; 12 weeks adjuvant docetaxel plus trastuzumab	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.; Drug: Docetaxel; Docetaxel 100mg/m2，d1，iv，q3w*4

Outcome Measures

Primary Outcome Measures :

1. Disease-free Survival [ Time Frame: 3-year estimates ]
   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.

Secondary Outcome Measures :

1. Breast Cancer Specific Survival [ Time Frame: 3-year estimates ]
   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.
2. Overall Survival [ Time Frame: 3-year estimats ]
   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. Treatment-related adverse events [ Time Frame: up to 4 months ]
   Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
4. Change of LVEF after treatment [ Time Frame: up to 4 months ]
   The change of LVEF after 12 weeks treatment compared to the baseline LVEF

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

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Contacts and Locations

Contacts

Contact: Jiayi Wu, doctor; 8621-64370045 ext 602268; pinkscorpio@163.com

Locations

China, Shanghai

Ruijin Hospital; Recruiting

Shanghai, Shanghai, China, 200025

Contact: Shuning Ding, doctor 64370045 ext 602215 nannanyard@163.com

Sponsors and Collaborators

Ruijin Hospital

Investigators

• Principal Investigator: Li Zhu, doctor; Shanghai Jiao Tong University School of Medicine

More Information

• Responsible Party: Li Zhu, Professor, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03367676
• Other Study ID Numbers: RJBC1712
• First Posted: December 11, 2017
• Last Update Posted: March 10, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Zhu, Ruijin Hospital:

trastuzumab; adjuvant therapy

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Docetaxel; Trastuzumab; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological