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

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT07748260
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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×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.

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2031
Completion
Jul 1, 2031

Study Design

Enrollment
592 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: THP×4
    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)
  • Active Comparator: THP×6
    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)

Primary Outcome Measure

pCR [ Time Frame: 18 weeks. ]

Central Contacts

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