Dynamic Observational Study With PET of 68Ga-HER2-affibody in Anti-HER2 Treatment

NCT04769050 | Unknown

• 1 other identifier: DOLPHIN
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dynamic observationaL study with PET of 68Ga-HER2-affibody in anti-HER2 treatment

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and ORR.

  The correlation between the percent change in standardized uptake value (SUV) on 68Ga-Affibody HER-2 Imaging PET at baseline and after 2 courses of treatment and objective response rate(ORR).

  2 year

Secondary Outcomes (4)

• The correlation between the change of HER2-PET at baseline and after 2 courses of treatment and PFS

  2 year

• The correlation between baseline HER2 expression and ORR, PFS

  2 year

• The correlation between heterogeneity of baseline HER2 expression and ORR, PFS

  2 year

• To explore the condition of HER2-PET when PD.

  2 year

Study Arms (2)

First-line patients

First-line treatment of HER2-positive metastatic breast cancer patients

Drug: Docetaxel combined with Trastuzumab±Pertuzumab

Second-line patients

Second-line treatment of HER2-positive metastatic breast cancer patients

Drug: T-DM1 or Capecitabine combined with Pyrotinib regimen.

Interventions

Docetaxel combined with Trastuzumab±Pertuzumab DRUG

Docetaxel, 75 mg/m2 ivgtt d1 q3w Trastuzumab, 6 mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Pertuzumab, 420mg(840mg for initial dose) ivgtt d1 q3w

First-line patients

T-DM1 or Capecitabine combined with Pyrotinib regimen. DRUG

T-DM1, 3.6mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Capecitabine, 1250 mg/m2 bid po d1-14 q3w Pyrotinib, 400mg po daily (continuously)

Second-line patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2 positive recurrent or metastatic breast cancer

You may qualify if:

• Subjects voluntarily joined the study, signed informed consent, and had good compliance.
• Female patients aged over 18 years (including cutoff value).
• an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Patients with HER2 positive recurrent or metastatic breast cancer confirmed by histopathology.
• At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
• Previously received no more than 1 prior lines of systemic chemotherapy for metastatic breast cancer
• Life expectancy ≥ 12 weeks.
• Adequate function of major organs meets the following requirements (no blood components and cell growth factors have been used within 14 days before randomization):
• Neutrophils ≥ 1.5×10\^9/L
• Platelets ≥ 75×10\^9/L
• Hemoglobin ≥ 80g/L
• Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
• ALT and AST ≤ 3 × ULN
• BUN and Cr ≤ 1.5 × ULN
• Left ventricular ejection fraction (LVEF) ≥ 50%

You may not qualify if:

• The subject has untreated central nervous system (CNS) metastases.
• Patients who have undergone systemic, radical brain or meningeal metastasis (radiotherapy or surgery), but have been confirmed to have been stable for at least 4 weeks, and who have stopped systemic hormonal therapy for more than 2 weeks without clinical symptoms can be included.
• Received systemic therapy such as chemotherapy, molecular targeted therapyment;received endocrine therapy within 2 weeks before enrollment.
• Patients with other malignant tumors within 3 years or at the sametime(except for cured skin basal cell carcinoma and cervical carcinomain situ).
• Have undergone major surgical procedures or significant trauma within 4 weeks prior to randomization, or are expected to undergo major surgery.
• Pregnant women, lactating female, or women of childbearing age who are unwilling to take effective contraceptive measures.
• Have a history of allergies to the drug components of this regimen.
• Patients with active HBV and HCV infection; stable hepatitis B after drug treatment (HBV virus copy number is higher than the upper limit of reference value) and cured hepatitis C patients (HCV virus copy number exceeds the lower limit of detection method).
• History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
• History of cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction (4)heart failure (5) other cardiac dysfunction (judged by the physician); any cardiac or nephric abnormal ≥ grade 2 found in screening.
• Female patients who are pregnancy, lactation or women who are ofchildbearing potential tested positive in baseline pregnancy test.
• Childbearing female who refuse to accept any contraception practice.
• Determined by the physician, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,active infection etc.).
• History of neurological or psychiatric disorders, including epilepsy or dementia.
• Severe infections within 4 weeks prior to first dose (eg, intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical protocols), or unexplained fever (T \> 38.3 °C ) during screening or prior to first administration

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, MD, PhD

CONTACT

64175590; huxicun@gmail.com

Jian Zhang, M.D.

CONTACT

64175590; syner2000@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical oncology

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 24, 2021
• Study Start: February 18, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)