De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast

NCT07748260 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: KY2026-686-01
• Study Type: interventional
• Target: 592
• Locations: 0 countries
• Sites: N/A

Brief Summary

High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients. Total pCR rates in breast and axilla have been described as high as 64%, and with an even higher rate of \>80% in patients with HER2-positive and hormone receptor (HR) negative tumors. pCR is associated with better long-term outcomes in patients with HER2-positive breast cancer. Neoadjuvant treatment of HER2-positive breast cancer typically consists of six cycles of treatment. Longer duration of treatment is associated with higher pCR-rates but also with increased toxicity. It is therefore important to investigate which patients can safely be treated with less than six cycles of chemotherapy and which patients require six cycles for maximum efficacy.It is hypothesized that patients with a complete pathologic response may not benefit from additional chemotherapy, while those with residual invasive disease require further treatment. This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• pCR

  The primary endpoint was locally determined pathological complete response(pCR, ypT0/is, ypN0).

  18 weeks.

Study Arms (2)

THP×4

EXPERIMENTAL

THP×4 Q3W (n=296) (Investigator-selected taxane\* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)

Drug: THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)

THP×6

ACTIVE COMPARATOR

THP×6 Q3W (n=296) (Investigator-selected taxane\* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)

Drug: THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)

Interventions

THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg) DRUG

This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.

THP×4

THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg) DRUG

This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.

THP×6

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically confirmed HER2-positive invasive breast cancer; Clinical staging of disease classified as T2N0M0.

You may not qualify if:

• Patients who have undergone chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this condition; Due to severe and uncontrolled medical conditions, the investigator deems chemotherapy contraindicated.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Central Study Contacts

Kun Wang

CONTACT

+8613922118086; wangkun@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: August 5, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share