Breast NeoplasmsPhase 2HER2CellNCT04993014
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
A Phase 2 study testing Pertuzumab, Trastuzumab and Circulating tumor cells in people with Breast Neoplasms and HER2-positive Breast Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell
- What is being tested?
- Pertuzumab, Trastuzumab and Circulating tumor cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2021to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
A.C. Camargo Cancer Center
São Paulo, 01525-001
Marcelle G Cesca, MD, +551121895000, marcelle.cesca@accamargo.org.br
Ludmilla TD Chinen, PhD, +551121895000, ludmilla.chinen@accamargo.org.br
About this study
Official title: Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
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.
Read the 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
- Being tested
- Pertuzumab, Trastuzumab, Circulating tumor cells
- Medical subject headings
- Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Also called Perjeta
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
TrastuzumabDrug
Also called Zedora
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
Circulating tumor cellsOther
Also called CTCs
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Arm A - trastuzumab | Active comparator | Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline Receives: Drug: Trastuzumab; Other: Circulating tumor cells |
| Cohort 1, Arm B - Trastuzumab + pertuzumab | Experimental | Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline Receives: 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 Receives: 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 Receives: Drug: Pertuzumab; Drug: Trastuzumab; Other: Circulating tumor cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2 therapy disease-free survival
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline
Adverse events
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Measured: Adjuvant period (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Mar 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelle Goldner Cesca, AC Camargo Cancer Center
- Investigators
- Marcelle G Cesca, MD, Principal investigator, A.C. Camargo Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993014
- Sponsor's protocol ID
- 2861/20
- Acronym
- HER2Cell
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
- ClinicalTrials.gov ID
- NCT04993014
- Acronym / sponsor ID
- HER2Cell / 2861/20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Arm A - trastuzumab | Active comparator | Drug: Trastuzumab, Other: Circulating tumor cellsAdjuvant trastuzumab for patients with HER2 positive CTCs at baseline |
| Cohort 1, Arm B - Trastuzumab + pertuzumab | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Other: Circulating tumor cellsAdjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline |
| Cohort 2, Arm A - trastuzumab | Active comparator | Drug: Trastuzumab, Other: Circulating tumor cellsAdjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline |
| Cohort 2, Arm B - Trastuzumab + pertuzumab | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Other: Circulating tumor cellsAdjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PertuzumabAlso: PerjetaAdjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) | Drug | Cohort 1, Arm B - Trastuzumab + pertuzumab, Cohort 2, Arm B - Trastuzumab + pertuzumab |
| TrastuzumabAlso: ZedoraAdjuvant 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 | Drug | Cohort 1, Arm A - trastuzumab, Cohort 1, Arm B - Trastuzumab + pertuzumab, Cohort 2, Arm A - trastuzumab, Cohort 2, Arm B - Trastuzumab + pertuzumab |
| Circulating tumor cellsAlso: CTCsBlood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done. | Other | Cohort 1, Arm A - trastuzumab, Cohort 1, Arm B - Trastuzumab + pertuzumab, Cohort 2, Arm A - trastuzumab, Cohort 2, Arm B - Trastuzumab + pertuzumab |
Primary outcome
HER2 therapy disease-free survival
Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
CTCs disease-free survival
Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
3 secondary outcomes
Prognostic factors for disease-free survival
Time frame: At baseline and adjuvant therapy (18 months)
Correlation of CTCs and pathological complete response
Time frame: At baseline
Adverse events
Time frame: Adjuvant period (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcelle G Cesca, MD principal investigator
A.C. Camargo Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pertuzumab, Trastuzumab and Circulating tumor cells in people with Breast Neoplasms and HER2-positive Breast Cancer, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcelle G Cesca, MD (+551121895000, marcelle.cesca@accamargo.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2 therapy disease-free survival (time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.