Real World Study on the Efficacy and Safety of Anti-HER2 Therapy

NCT05367739 | Completed

• 1 other identifier: Real-HER2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasms; HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR)

  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)

  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

  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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: June 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-07

Locations

CN (1)