Clinical trial NCT04993014: Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Official title: Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Neoplasms
HER2-positive Breast Cancer
Circulating Tumor Cell
Lead sponsor: AC Camargo Cancer Center
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients will be divided into 2 cohorts, based on HER2 positivity in CTCs at baseline of neoadjuvant therapy.

Cohort 1: HER2 positive CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response Cohort 2: HER2 negative/absent CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response
Primary purpose: TREATMENT

Brief summary: Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline.

Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.

Detailed description: Patients with HER2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included.

Blood samples will be collected at baseline (before neoadjuvant start) for the analysis of CTCs and its positivity for HER2 by IHC and ISH.

Patients with pathological complete response will be included in the randomization phase of the study. There will be 2 cohorts: HER2 positive CTCs at baseline and HER2 negative/absent CTCs at baseline. In each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab

Eligibility criteria: Inclusion Criteria:

* HER2 positive breast cancer (hormone receptors positive or negative)
* Stage I to III
* Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
* Breast surgery after neoadjuvant therapy
* Preserved coagnition
* ECOG 0-3
* For the randomization phase: pathological complete response (ypT0/ypTis and ypN0)
* Agreement on participation and signature of de ICF

Exclusion Criteria:

* Contradindication for trastuzumab or pertuzumab
* Adjuvant chemotherapy. Hormone therapy is allowed
* Second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer

Primary outcomes:
measure: HER2 therapy disease-free survival
timeFrame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
measure: CTCs disease-free survival
timeFrame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Secondary outcomes:
measure: Prognostic factors for disease-free survival
timeFrame: At baseline and adjuvant therapy (18 months)
measure: Correlation of CTCs and pathological complete response
timeFrame: At baseline
measure: Adverse events
timeFrame: Adjuvant period (1 year)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: A.C. Camargo Cancer Center
Study officials:
affiliation: A.C. Camargo Cancer Center
name: Marcelle G Cesca, MD
role: PRINCIPAL_INVESTIGATOR
References: