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Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer (SHERO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158856
Recruitment Status : Not yet recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
xuexin he, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Drug: Pyrotinib Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors < 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Experimental Arm
adjuvant Pyrotinib plus Trastuzumab
Drug: Pyrotinib
400mg po every day
Other Name: Pyrotinib Maleate Tablets

Drug: Trastuzumab
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days
Other Name: Herceptin




Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 5 years ]
    stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.


Secondary Outcome Measures :
  1. Breast Cancer Specific Survival [ Time Frame: 5 years ]
    Estimated percentage of patients alive and disease-free at 5 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: 5 years ]
    Estimated percentage of patients alive and disease-free at 5 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 3 months ]
    Incidence and severity of adverse events as assessed by NCI CTCAE V5.0

  4. Change of LVEF after treatment [ Time Frame: up to 3 months ]
    The change of LVEF after 3 months treatment compared to the baseline LVEF



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged 18-70 years old
  2. Have finished radical operation
  3. Histologically confirmed invasive ductal carcinoma (IDCA)
  4. According to AJCC ,pT<8mm, pN0, no evidence for metastasis
  5. Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2), nuclear grade 3.
  6. Should have tumor tissue available and sufficient for multi-spots sampling.
  7. It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
  8. Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months
  9. Cardiac function had to be within normal limits (left ventricular ejection fraction [LVEF] ≥50%), as established by multiple gated acquisition scan or echocardiography.
  10. Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
  11. 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.
  12. Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

  1. pT≥8mm or node positive
  2. Metastatic breast cancer
  3. Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
  4. With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
  5. Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
  6. Has symptomatic peripheral neuropathy > grade 2 according to NCI
  7. Known severe allergy to any drugs in this study
  8. Has cardiac dysfunction or lung dysfunction defined as follows:

    • grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
    • angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
    • uncontrolled high-risk arrhythmia
    • uncontrolled hypertension
  9. Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
  10. Patient is pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158856


Contacts
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Contact: Xuexin He, MD +86-18329139569 xuexinhe@zju.edu.cn

Sponsors and Collaborators
xuexin he
Investigators
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Study Chair: Xuexin He, MD Seaond Affiliated Hospital, Zhejiang University, School of Medicine
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Responsible Party: xuexin he, Associate chief physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04158856    
Other Study ID Numbers: SHERO
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents