NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

Sponsor
West German Study Group
Study ID
NCT06081244
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Sacituzumab govitecan — DRUG
    10 mg/kg twice on Days 1 and 8 of a continuous 21-day treatment cycle
  • Pembrolizumab — DRUG
    200 mg every 3 weeks (q3w)

Study Details

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.

Key Dates

First listed
Oct 13, 2023
Start date
Oct 10, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

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

Arms

  • Experimental: Neoadjuvant treatment: 12 weeks (4 cycles) SG i.v.
    * Cohort 1a: In case of (near) cCR: end of treatment, followed by surgery * Cohort 1b: In case of cPR after 12 weeks: further 6 weeks (2 cycles) SG i.v., followed by surgery (use of core biopsy is allowed per investigator´s decision, if further NACT is planned) pCR dependent post-neoadjuvant treatment * In case of pCR: no further systemic treatment * In case of non-pCR: chemotherapy according to investigators decision, e.g., AC/EC q3w x 4, PAC/Carbo q1w x 12
  • Experimental: Neoadjuvant treatment: 12 weeks (4 cycles) SG+PEM i.v.
    * Cohort 2a: In case of (near) cCR: end of treatment, followed by surgery * Cohort 2b: In case of cPR after 12 weeks: 6 weeks (2 cycles) SG+PEM i.v., followed by surgery (use of core biopsy is allowed per investigator´s decision, if further NACT is planned) pCR dependent post-neoadjuvant treatment * In case of pCR: no further systemic treatment * In case of non-pCR: chemotherapy according to investigators decision, e.g., AC/EC q3w x 4, PAC/Carbo q1w x 12

Primary Outcome Measure

pathological complete remission (pCR) [ Time Frame: at surgery ]

Central Contacts

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