Clinical Trial on Breast Neoplasms, HER2-positive Breast Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Detailed Description

About 30% of breast cancer is human epidermal growth factor receptor-2 (HER2) amplification or overexpression (i.e. HER2 positive). HER2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. Anti HER2 therapy can improve the survival of HER2 positive patients and reduce mortality. The aim of the open-label, real-world study is to assess efficacy and safety of Anti-HER2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (TKIs) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (DS-8201) and trastuzumab emtansine (T-DM1).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Hunan
  - Changsha, Hunan, China, 410013
    - Hunan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

HER2 positive breast cancer patients who plan to receive anti-HER2 therapy

Description

Inclusion Criteria:

Age ≥ 18 years old, voluntary consent and signed written informed consent.
ECOG 0~2.
Diagnosis of locally advanced (stage IIIB or IIIC) or metastatic (stage IV) breast cancer.
At least one measurable disease lesion before treatment.
Anticipated survival time is longer than three months.
Pathological and IHC reports for ER, PR, HER2 and Ki67 are available.
For women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment
There are traceable medical records during treatment.

Exclusion Criteria:

Pregnant or lactating women. Active infection requiring systemic treatment。
HIV positive
Suffering from or suspected of suffering from central nervous system diseases.
Serious heart disease.
Pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen
The investigator considered that the patient was not suitable for in this study, with any other situation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Time Frame: From date of randomization until the date at the end of the second treatment cycle (42 days)	The total rate of CR+PR after the completion of two cycles of treatment.	From date of randomization until the date at the end of the second treatment cycle (42 days)
Progression-Free Survival (PFS) Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	The survival time from the date of recruitment to the date of the first documented progression or date of death.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Adverse Events Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	All adverse events [including adverse events (AE / SAE) and ADR (adverse drug reactions)] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified