A real world study of pyrrolidone maleate in the treatment of early / locally advanced HER2 positive breast cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2100049135

Enrollment

Unknown

Registered

2021-07-22

Start date

2021-09-13

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

Case series:None

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years old; 2. Clinical stage II to III new breast cancer patients were diagnosed with HER2 positive breast cancer by core needle biopsy pathology or histology before treatment. HER2 positive was defined as confirmed by pathological laboratory confirmed immunohistochemical staining (IHC), HER2 (3 +) or HER2 (2 +) and in situ hybridization (ISH) detection; 3. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with recurrent and metastatic breast cancer ; 2. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect the drug taking and absorption; 3. Suffering from mental illness or abuse of psychotropic substances and unable to cooperate; 4. Pregnant or lactating women; 5. The researcher thinks that it is not suitable to be enrolled.

Design outcomes

Primary

Measure	Time frame
Pathological complete remission rate;disease free survival;	—

Countries

China

Contacts

Public ContactNie Jianyun

Jiangsu Hengrui Pharmaceutical Co., Ltd

niyvip_susar@163.com+86 13608815577

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026