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Real World Study on the Efficacy and Safety of Trastuzumab Combined With Delayed Pertuzumab Application in the Treatment of HER2 Positive Breast Cancer: an Observational, Non-Interventional, Prospective Study

Real World Study on the Efficacy and Safety of Trastuzumab Combined With Delayed Pertuzumab Application in the Treatment of HER2 Positive Breast Cancer: an Observational, Non-Interventional, Prospective Study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000032568
Enrollment
Unknown
Registered
2020-05-02
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-05-04

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

Conditions

Breast Cancer

Interventions

The Grop of Trastuzumab :Only used Trastuzumab
The Grop of Trastuzumab with Pertuzumab delayed:Trastuzumab combined with delayed Pertuzumab

Sponsors

Guangdong Provincinal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The histological examination after surgery confirmed diagnosis of breast cancer with HER2 positive (following the 2018 ASCO/CAP HER2 guidelines, positive of HER2 referred to histological confirming that the IHC score of primary focus or metastasis focus was 3+ or 2+ and ISH test was positive as well). 2. Histological confirmed lymph node metastasis. 3. Female, aged >= 18 years. 4. Histological confirmed non-metastatic and operable primary invasive breast cancer with HER2 positive, and possible for thorough resection. 5. ECOG performance status 0 or 1 (criteria of ECOG(Eastern Clinical Oncology Group): 0: normal performance; 1, with symptoms, with ability of self-care and with no need to stay in bed). 6. Identified hormone receptor (ER and PGR). 7. LVEF >= 55%, measured with echocardiography.

Exclusion criteria

Exclusion criteria: 1. Any previous invasive breast cancer history (same side and/or offside). 2. Any malignant carcinoma except breast cancer within 5 years before investigation start. 3. Any clinically defined T4 cancer according to primary tumor / regional lymph node / distant metastasis (TNM) standards, including inflammatory breast carcinoma. 4. Any previous systemic chemotherapy or radiotherapy of cancer. 5. Sever cardiac or cardiovascular diseases. 6. Any other server diseases that may interfere with treatment, including severe pulmonic disease. 7. Pregnant or breast-feeding patients. 8. Known hypersensitivity or anaphylactic reaction to the study drugs or their ingredients.

Design outcomes

Primary

MeasureTime frame
IDFS;—

Secondary

MeasureTime frame
PFS;OS;DCR;ORR;—

Countries

China

Contacts

Public ContactQianjun Chen

Guangdong Provincinal Hospital of Traditional Chinese Medicine

cqj55@163.com+86 18688883505

Outcome results

None listed

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