Real World Study on the Efficacy and Sa… | Clinical Trial

Key information

Conditions

Breast Neoplasms Breast Diseases HER2-positive Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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.
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.
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.

Sponsors and collaborators

Lead sponsor

Hunan Cancer Hospital

Other

Registry information

Official study title

A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: May 10, 2022
Registry last updated: Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed