Trastuzumab and Pertuzumab for HER2 Positive Breast Cancer
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Recruiting
Phase 2Interventional Study
Breast NeoplasmsHER2-positive Breast CancerCirculating Tumor Cell
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
AC Camargo Cancer Center · Other
Who this trial is looking for
This trial is looking for women with early HER2 positive breast cancer who will receive initial treatment with chemotherapy and specific medications. Participants will provide blood samples and may be assigned to continue with one or both medications after surgery, depending on their response to treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with HER2 positive breast cancer
I am at Stage I to III
I need neoadjuvant therapy with chemotherapy, trastuzumab, and pertuzumab
I will have breast surgery after the initial treatment
I have good cognitive function
My ECOG performance status is 0-3
I have a complete response to the initial therapy
I agree to participate and will sign the consent form
You may not be able to join if
I cannot take trastuzumab or pertuzumab
I am receiving adjuvant chemotherapy
I have had a second primary tumor in the last 5 years, except for treated non-melanoma skin cancer or in situ cervical cancer
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Status
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 p…
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
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