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A prospective, open, single-arm, real-world study comparing the results of the WSG-Adapt HER-2+ series of weekly paclitaxel combined with dual target neoadjuvant therapy for breast cancer with POSITIVE HER-2

A prospective, open, single-arm, real-world study comparing the results of the WSG-Adapt HER-2+ series of weekly paclitaxel combined with dual target neoadjuvant therapy for breast cancer with POSITIVE HER-2

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054127
Enrollment
Unknown
Registered
2021-12-09
Start date
2021-12-08
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Breast cancer

Interventions

single-arm group:Solvent-based paclitaxel or paclitaxel injection (albumin-bound)combined with HP

Sponsors

Maoming People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. HER2-positive Stage II-III locally advanced breast cancer confirmed by pathological examination, who have not received any anti-tumor therapy before; 2. hormone receptor status is known; 3. Female, aged 18 to 70 years; 4. LVEF>=55%; 5. The ECOG score was 0 or 1, and follow-up treatment was assessed; they volunteered to join the study, signed informed consent, had good compliance and were willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating female patients, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 2. Patients with severe cardiovascular and cerebrovascular or mental related diseases; 3. Those who have used research drugs in other clinical trials 4 weeks before enrollment; 4. Patients with bilateral breast cancer and inflammatory breast cancer; 5. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, etc.); the investigator believes that the patient is not suitable to participate in this study. any other circumstances of the study.

Design outcomes

Primary

MeasureTime frame
pathological complete response rate;

Secondary

MeasureTime frame
objective response rate;Pathological complete remission rate of breast tumor;3-year invasion-free survival;

Countries

China

Contacts

Public ContactShen Meiying

Maoming People's Hospital

18824384689@163.com+86 18824384689

Outcome results

None listed

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