HER2-positive Breast Cancer Project Initiated by Investigators

NCT05346328 | Unknown Phase 2

• 1 other identifier: KL166-IIS-001
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.

Conditions

Breast Cancer

Keywords

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate（ORR）

  ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1.

  2 years

Secondary Outcomes (6)

• Progression-free survival(PFS)

  2 years

• Disease control rate(DCR)

  2 years

• Clinical benefit rate(CBR)

  2 years

• Duration of rate(DOR)

  2 years

• Time to response(TTR)

  2 years

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.

Drug: Injection of A166

Interventions

Injection of A166 DRUG

4.8 mg/kg for each 21 (±3) -day cycle

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form; 2. Breast cancer patients by histopathology and/or cytology documented, including:
• a) Participants with unresectable locally advanced or metastatic breast cancer; b) Evaluated or tested as HER2-positive expression. The definition of HER2 positive in this study: immunohistochemistry (IHC) was 2+ and confirmed by fluorescence in situ hybridization (FISH), or IHC was 3+; 3. Have received at least 3 targeted therapies for locally advanced or metastatic disease, including:
• Disease progression after receiving at least 1 trastuzumab-containing (including a biosimilar of trastuzumab on the market)-based treatment;
• After receiving at least one anti-HER2 tyrosine kinase inhibitor (lapatinib or pyrrotinib)-based treatment plan, the disease progresses or cannot tolerate toxic and side effects;
• The disease progresses or cannot tolerate toxic and side effects after receiving treatment with antibody-conjugated drugs targeting HER2 (such as T-DM1 or other ADCs); Note: Adjuvant therapy and anti-HER2 therapy used in the neoadjuvant treatment stage before radical treatment are not counted, but recurrence or metastasis occurs during the last anti-HER2 medication period or within one year after the end, it can be regarded as a plan.
• \. Have previously received taxanes to treat breast cancer;

You may not qualify if:

• \. Serious or uncontrollable heart diseases that require treatment, including:
• Congestive heart failure graded 3 or 4 by the New York College of Cardiology (NYHA);
• Unstable angina pectoris that cannot be controlled by drugs;
• Myocardial infarction occurred within 6 months before the first administration of the study treatment;
• Severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 2. Baseline measurement, QTc interval, male\> 450 msec, female\> 470 msec; 3. Clinically active interstitial lung disease; 4. Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that have failed local treatment; for asymptomatic brain metastases, or with stable clinical symptoms and no need for steroids and other brain metastases within 4 weeks before the first administration of the trial drug Treated patients can be included in the group; 5. Those who are known to have a history of hypersensitivity to other monoclonal antibodies or allergic to A166 and its components for injection; 6. Those who have permanently discontinued trastuzumab due to any toxicity;

Sponsors & Collaborators

• Fudan University: lead

Related Publications (2)

• Krop IE, Kim SB, Gonzalez-Martin A, LoRusso PM, Ferrero JM, Smitt M, Yu R, Leung AC, Wildiers H; TH3RESA study collaborators. Trastuzumab emtansine versus treatment of physician's choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):689-99. doi: 10.1016/S1470-2045(14)70178-0. Epub 2014 May 2.

  PMID: 24793816 RESULT

• Krop IE, Kim SB, Martin AG, LoRusso PM, Ferrero JM, Badovinac-Crnjevic T, Hoersch S, Smitt M, Wildiers H. Trastuzumab emtansine versus treatment of physician's choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial. Lancet Oncol. 2017 Jun;18(6):743-754. doi: 10.1016/S1470-2045(17)30313-3. Epub 2017 May 16.

  PMID: 28526538 RESULT

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Xichun Hu, Doctor

  Chief Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xichun Hu, Doctor

CONTACT

18017312175; xchu2009@hotmail.com

Jian Zhang, Master

CONTACT

13918273761; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: April 26, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 26, 2022

Record last verified: 2022-04