A Phase 2 interventional study of Pertuzumab and Trastuzumab in Breast Neoplasms, HER2-positive Breast Cancer and Circulating Tumor Cell, sponsored by AC Camargo Cancer Center. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by AC Camargo Cancer Center · Phase 2, Interventional, and Treatment
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.
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 80 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AC Camargo Cancer Center is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Drug: Pertuzumab · Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
Drug: Trastuzumab · Other: Circulating tumor cells
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Drug: Pertuzumab · Drug: Trastuzumab · Other: Circulating tumor cells
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
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
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Also known as: CTCs
HER2 therapy disease-free survival
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
Time frame: 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
Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Prognostic factors for disease-free survival
Time frame: At baseline and adjuvant therapy (18 months)
Correlation of CTCs and pathological complete response
To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response
Time frame: At baseline
Adverse events
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Time frame: Adjuvant period (1 year)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Apr 2024, 37 months after the start.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's planned 37 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Pertuzumab
AC Camargo Cancer Center