Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

NCT04993014 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2861/20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; HER2-positive Breast Cancer; Circulating Tumor Cell

Outcome Measures

Primary Outcomes (2)

• HER2 therapy disease-free survival

  To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms

  From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years

• CTCs disease-free survival

  To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs

  From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years

Secondary Outcomes (3)

• Prognostic factors for disease-free survival

  At baseline and adjuvant therapy (18 months)

• Correlation of CTCs and pathological complete response

  At baseline

• Adverse events

  Adjuvant period (1 year)

Study Arms (4)

Cohort 1, Arm A - trastuzumab

ACTIVE COMPARATOR

Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline

Drug: Trastuzumab; Other: Circulating tumor cells

Cohort 1, Arm B - Trastuzumab + pertuzumab

EXPERIMENTAL

Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline

Drug: Pertuzumab; Drug: Trastuzumab; Other: Circulating tumor cells

Cohort 2, Arm A - trastuzumab

ACTIVE COMPARATOR

Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline

Drug: Trastuzumab; Other: Circulating tumor cells

Cohort 2, Arm B - Trastuzumab + pertuzumab

EXPERIMENTAL

Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline

Drug: Pertuzumab; Drug: Trastuzumab; Other: Circulating tumor cells

Interventions

Pertuzumab DRUG

Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)

Also known as: Perjeta

Cohort 1, Arm B - Trastuzumab + pertuzumab; Cohort 2, Arm B - Trastuzumab + pertuzumab

Trastuzumab DRUG

Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts

Also known as: Zedora

Cohort 1, Arm A - trastuzumab; Cohort 1, Arm B - Trastuzumab + pertuzumab; Cohort 2, Arm A - trastuzumab; Cohort 2, Arm B - Trastuzumab + pertuzumab

Circulating tumor cells OTHER

Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.

Also known as: CTCs

Cohort 1, Arm A - trastuzumab; Cohort 1, Arm B - Trastuzumab + pertuzumab; Cohort 2, Arm A - trastuzumab; Cohort 2, Arm B - Trastuzumab + pertuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

A.C. Camargo Cancer Center

São Paulo, 01525-001, Brazil

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

pertuzumab; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Marcelle G Cesca, MD

  A.C. Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelle G Cesca, MD

CONTACT

+551121895000; marcelle.cesca@accamargo.org.br

Ludmilla TD Chinen, PhD

CONTACT

+551121895000; ludmilla.chinen@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Oncologist

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 6, 2021
• Study Start: March 1, 2021
• Primary Completion: April 30, 2024
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)