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Treatment of physician's choice, Pyrotinib combined with Trastuzumab among HER 2 positive breast cancer who are no response after receiving the neoadjuvant Trastuzumab and Pertuzumab regimens: a single-arm, multi-centre clinical exploratory study

Treatment of physician's choice, Pyrotinib combined with Trastuzumab among HER 2 positive breast cancer who are no response after receiving the neoadjuvant Trastuzumab and Pertuzumab regimens: a single-arm, multi-centre clinical exploratory study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043105
Enrollment
Unknown
Registered
2021-02-05
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

Breast cancer

Interventions

Experimental group:Pyrotinib, Capecitabine or Vinorelbine or Eribulin, combined with Trastuzumab

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with stage II (ct3n0m0) - III breast cancer confirmed by pathology; 2. Female, age >= 18 and <= 70 years; 3. Subjects with ECoG score of 0 or 1 were evaluated for tolerance to follow-up treatment; 4. Subjects who had received neoadjuvant regimen containing trastuzumab combined with patuzumab for at least 2 cycles and were assessed as SD (0-20% increase) or PD according to RECIST 1.1; 5. The volunteers signed informed consent, had good compliance and were willing to cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cardiovascular and cerebrovascular or mental diseases; 2. Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are not willing to take effective contraceptive measures during the whole trial period; 3. The patients who can't swallow, chronic diarrhea and intestinal obstruction have many factors that affect the drug taking and absorption; 4. Patients who had used the research drugs of other clinical trials in the first 4 weeks before enrollment; 5. Patients receiving any other anti-tumor therapy at the same time; 6. Patients with bilateral breast cancer and inflammatory breast cancer; 7. According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study (including but not limited to severe hypertension, severe diabetes, etc., which cannot be controlled by drugs); 8. The researcher thinks that the patient is not suitable for any other situation of this study.

Design outcomes

Primary

MeasureTime frame
Pathologic complete response;

Secondary

MeasureTime frame
Objective response rate;Disease free survival;

Countries

China

Contacts

Public ContactQianjun Chen, Rui Xu

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

cqj55@163.com+86 18688883505

Outcome results

None listed

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