Clinical trial NCT05367739: Real World Study on the Efficacy and Safety of Anti-HER2 Therapy
Official title: A Real-world Observational Study on the Efficacy and Safety of Anti HER2 Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
HER2-positive Breast Cancer
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HER2 positive breast cancer patients who plan to receive anti-HER2 therapy

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of randomization until the date at the end of the second treatment cycle (42 days)
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Adverse Events
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
References: