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NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

ConditionHER2-positive Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWest German Study Group

About this trial

ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.

ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

absolute neutrophil count ≥ 1.5 × 109/L,

platelets ≥ 100 × 109/L,

estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,

INR ≤ 1.5,

Disqualifiers

1. Non-operable breast cancer including inflammatory breast cancer

cT1a/b, cN0 breast cancer

Any previous history of invasive breast cancer

Primary malignancies within 5 years, with the exception of

Trial design

Design model

Crossover

Treatments tested in this trial

  • Trastuzumab deruxtecan

    Drug

    T-DXd i.v.

  • Standard-of-Care

    Drug

    Chemotherapy+T+P

Treatment groups

702 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: T-DXd 12 weeks: HER2+ and low-intermediate risk for recurrenceExperimental treatment 1 intervention
Group B: T-DXd 18 weeks: HER2+ and intermediate-high risk for recurrenceExperimental treatment 1 intervention
Group C: Control SoC CTx 12 weeks: HER2+ and low-intermediate risk for recurrenceOther 1 intervention
Group D: Control SoC CTx 18 weeks: HER2+ and intermediate-high risk for recurrenceOther 1 intervention
Group E: T-DXd 12 weeks + SoC CTx 6 weeksExperimental treatment 2 interventions
Group F: T-DXd 12 weeks + SoC CTx 12 weeksExperimental treatment 2 interventions
Group G: SoC CTx 18 weeksOther 1 intervention

Trial outcomes

Primary outcomes

1

Adverse drug reactions with CTCAE-grade 3 or higher, compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

Time frame
after 18 weeks of neoadjuvant treatment
2

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): T-DXd

dDFS in patients with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2)

Time frame
after 3 years
3

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): CTx

in patients with T-DXd neoadjuvant therapy followed by CHT (pooled experimental treatment arms of part 2, cohort 3)

Time frame
after 3 years
4

pCR rate after neoadjuvant treatment

defined as ypT0is/ypN0, compared between patients treated with T-DXd neoadjuvant monotherapy (pooled experimental treatment arms of part 1, pooled cohorts 1 and 2) compared to patients of corresponding standard-of-care treatments (DOC/PAC+T+P or DOC/PAC+Carbo+T+P) (pooled standard-of-care treatment arms of part 1, pooled cohorts 1 and 2)

Time frame
after 18 weeks of neoadjuvant treatment

Secondary outcomes

1

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 18 weeks

compared between patients treated with T-DXd neoadjuvant monotherapy for 18 weeks (part 1, cohort 2) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

Time frame
after 3 years
2

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 weeks

compared between patients treated with T-DXd neoadjuvant monotherapy for 12 weeks (part 1, cohort 1) and patients treated with SoC for 12 weeks (part 1, cohort 1) 2 and 3 pooled)

Time frame
after 3 years
3

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 plus 6 weeks

compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 6 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

Time frame
after 3 years
4

distant disease-free survival (dDFS, according to STEEP 2.0 criteria): 12 plus 12 weeks

compared between patients treated with T-DXd neoadjuvant therapy for 12 weeks followed by 12 weeks CHT (part 2, cohort 3) and patients treated with SoC for 18 weeks (part 1 and 2, cohorts 2 and 3 pooled)

Time frame
after 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West German Study Group

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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