Breast CancerPhase 2CHERRY-PICKNCT06068985
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade
A Phase 2 study testing PHESGO in people with Breast Cancer and HER2-positive Breast Cancer, run by Latin American Cooperative Oncology Group at 8 sites in Brazil.
Trial summary
This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- PHESGO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 8 sitesBrazil
- Study dates
- 5 Sep 2024to Nov 2032
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed ICF; Women between 18-80 years of age at time of signing ICF.
- ECOG ≤ 1
- HER2+ breast cancer with clinical stage at presentation: T1cN1, T2, N0-1
- HER2 3+ by IHC, with strongly positive staining for HER2 protein in ≥ 80% of cells, and absence of HER2 negative areas in the tumor
- ER IHC ≤10%
- PR IHC negative (<1%) or 0% of tumor cell nuclei
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- Tumors must have at least 10mm measured by breast echography and be assessable for SUVMax (maximum standardized uptake value (SUVmax) ≥ 2.5) using 18FDG-PET-CT scan on baseline imaging.
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research.
- Baseline LVEF ≥ 55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA).
- For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent (refrain from heterosexual intercourse) or use one highly effective non-hormonal contraceptive method with a failure rate of < 1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period.
- A negative serum pregnancy test must be available prior to randomization for WOCBP (premenopausal women and women < 12 months after the onset of menopause), unless they have undergone surgical sterilization (removal of ovaries and/or uterus)
Who cannot join
- Patients with metastatic disease.
- Any previous systemic chemotherapy or anti-HER2 targeted therapy directed to breast cancer.
- Patients with clinical N2 or N3 disease, T4, or inflammatory breast cancer.
- Concurrent serious diseases that may interfere with planned treatment.
- Patients with a history of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years.
- Patients who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy (selective estrogen receptor modulators, aromatase inhibitors, and antitumor vaccines) for treatment or prevention of breast cancer.
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- Patients who have a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment, or radiation therapy to the ipsilateral breast. Patients are allowed to enter the study if treated with surgery alone.
- Patients with high-risk for breast cancer who have received chemopreventive drugs in the past are not allowed to enter the study.
- Patients with bilateral breast cancer.
- Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes.
- Axillary lymph node dissection (ALND) or Sentinel lymph node biopsy (SLNB) prior to initiation of neoadjuvant therapy. Patients with clinically negative axilla (by physical examination and radiographic imaging) may undergo a core or needle biopsy procedure prior to neoadjuvant systemic therapy.
- Treatment with any investigational drug within 28 days prior to randomization.
- Serious cardiac illness or medical conditions.
- Inadequate bone marrow function.
- Impaired liver function.
- Inadequate renal function.
- Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders).
- Any major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment.
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy. Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study.
- Known active liver disease, for example, active viral hepatitis infection (i.e., hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis.
- Concurrent, serious, uncontrolled infections, or known infection with HIV.
- Known hypersensitivity to study drugs, excipients, and/or murine proteins.
- Current chronic daily treatment with corticosteroids (dose > 10 mg methylprednisolone or equivalent excluding inhaled steroids).
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma.
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe LVSD, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Oncocentro Belo Horizonte (Oncoclínicas)
Belo Horizonte, Minas Gerais, 30.360-680
Universidade Estadual de Campinas - UNICAMP
Campinas, São Paulo, 13.083-881
Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS - CPO
Porto Alegre, Rio Grande do Sul, 90.610-000
Instituto Nacional de Câncer - INCA
Rio de Janeiro, Rio de Janeiro, 20.230-130
Núcleo de Oncologia da Bahia - NOB (Oncoclínicas)
Salvador, Estado de Bahia, 40.170-110
Centro Paulista de Oncologia (Oncoclínicas)
São Paulo, São Paulo, 04.538-135
Hospital de Amor de Barretos
São Paulo, São Paulo, 14.784-400
Hospital da Fundação Oswaldo Aranha - HFOA
Volta Redonda, Rio de Janeiro, 27.251-260
About this study
This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy. The approach involves utilizing specific biomarkers (HR and HER2 IHC status) to select participants whose tumors strongly rely on the HER2 pathway, potentially benefiting from a HER2-targeted approach without chemotherapy concurrently.
Read the detailed description
This is a nonrandomized phase II single arm study to assess de-escalation of chemotherapy in participants with HER2-positive early breast cancer undergoing neoadjuvant therapy with PHESGO™. Participants will be evaluated by central laboratory review for confirmation of selected biomarkers (pre-screening). Participants who meet the biomarker assessment criteria will follow the eligibility criteria assessment. Participants with HER2 positive disease that meet the eligibility criteria will be treated with neoadjuvant PHESGO™.
A baseline PET/CT will be performed prior to start of PHESGO™ treatment. All participants will receive fixed-dose subcutaneous formulation with pertuzumab and trastuzumab (PHESGO™) every 21 days for 3 cycles to evaluate PET/CT response. After the 3rd cycle, participants achieving PET/CT response (defined in this trial as ≥40% reduction in the SUVMax as calculated by the formula SUVbaseline SUVresponse/SUVbaseline) will continue treatment with PHESGO™ for 5 additional cycles, completing 8 neoadjuvant cycles of PHESGO™. Participants without PET/CT response after 3rd cycle will be out of study and will receive treatment and surgery according to institutional standard of care. For this cohort of participant, data regarding treatment received, pCR status and outcomes will be collected.
Definitive breast cancer surgery will be performed after the 8th cycle of therapy. After surgery, participants will receive adjuvant treatment according to their response. Participants achieving pCR will receive PHESGO™ alone as adjuvant treatment to complete a total of one year of therapy, thus receiving 10 cycles of adjuvant PHESGO™. Participants not achieving pCR will receive one of two adjuvant therapy options as per investigator's choice: (1) 14 cycles of trastuzumab emtansine (T-DM1), or (2) investigator's choice chemotherapy regimen (up to 6 cycles) plus 10 cycles of PHESGO™. Disease status and survival data collection will be abstracted from medical records for up to 5 years after surgery.
Participants will be followed for recurrence and survival data with abstraction of data from medical records every 3 months in first year after surgery; every 4 months in second and third years; and then annually until five years. Medical procedures and therapies in the follow-up period are not a formal investigational part of this clinical trial and therefore will be performed according to the institutional standard of care.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- PHESGO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PHESGODrug
Subcutaneous formulation with pertuzumab and trastuzumab.
| Study group | Role | What they receive |
|---|---|---|
| PHESGO™-Based Neoadjuvant Therapy for HER2-Positive Early Breast Cancer | Experimental | This is a single-arm phase II neoadjuvant study using PHESGO™. Participants will receive three cycles of neoadjuvant PHESGO™, with a specific dosage regimen. After three cycles, participants will be reevaluated based on their PET-CT response. PET-CT response is defined as a ≥40% reduction in SUVMax without metabolic progression in non-target lesions. Responders will receive 5 additional cycles of PHESGO™ before surgery. Non-responders will exit the study, following institutional guidelines. Local surgery follows 8 cycles. Adjuvant therapy varies based on pCR status: 1 year of PHESGO™ for pCR; T-DM1 for 14 cycles or investigator's choice chemotherapy plus 10 additional adjuvant cycles of PHESGO™ for non-pCR cases. Receives: Drug: PHESGO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
This outcome measures the rate of participants with HER2-positive early breast cancer who achieve a pathologic complete response (pCR) following neoadjuvant treatment with PHESGO™ without concurrent chemotherapy. Participants selected based on high HER2 pathway dependence and demonstrating a favorable PET-CT response after the third therapy cycle are evaluated for the absence of residual invasive tumor cells in the breast and lymph nodes.
Measured: After eight neoadjuvant cycles of PHESGO™ (each cycle is 21 days)
Secondary outcomes (9)
Rate of Favorable PET-CT Response
Measures the percentage of participants showing a ≥40% reduction in SUVMax on PET-CT after three cycles of neoadjuvant PHESGO™. Responders demonstrate significant SUVmax reduction with no metabolic progression in non-target lesions.
Measured: After three neoadjuvant PHESGO™ cycles (each cycle is 21 days)
Pathologic Response via Residual Cancer Burden (RCB)
Evaluates pathologic response using the Residual Cancer Burden (RCB) tool, available at the provided link. RCB is assessed to determine the extent of residual cancer after treatment, aiding in treatment response evaluation.
Measured: Immediately after the end of treatment
Objective Response Rate by PERCIST 1.0
Measures the percentage of participants achieving complete metabolic response (CMR) or partial metabolic response (PMR) as per PERCIST 1.0 criteria, assessed by site radiology review after three cycles of neoadjuvant PHESGO™. Metabolic response assessment follows the Radiology Assessment section guidelines.
Measured: After three neoadjuvant PHESGO™ cycles (each cycle is 21 days)
Objective Response Rate by RECIST 1.1
Measures the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria from enrollment to eight cycles of neoadjuvant PHESGO™, among those who complete neoadjuvant treatment. Evaluation will be conducted by the local investigator in accordance with RECIST criteria version 1.1.
Measured: After eight neoadjuvant cycles of PHESGO™ (each cycle is 21 days)
Invasive Disease-Free Survival (iDFS) Stratified by pCR
Measures the time from enrollment to any occurrence of invasive disease, stratified by the presence or absence of pathologic complete response (pCR). Events for iDFS include death from any cause, locoregional or distant recurrence, new breast cancer (ipsilateral or contralateral), and second primary invasive cancer. Invasive breast cancer ipsilateral to the treatment disease is considered a recurrence. Data will be recorded regardless of therapy withdrawal after the first dose. Participants without these events at analysis times will be censored at the latest assessment date.
Measured: From enrollment until an event related to invasive disease occurs, stratified by pCR, assessed up to 5 years
Event-Free Survival (EFS) Stratified by pCR
Measures the time from enrollment to the occurrence of specific events, stratified by the presence or absence of pathologic complete response (pCR). Events for EFS include death from any cause, locoregional or distant recurrence, new breast cancer (ipsilateral or contralateral), cancer progression, and second primary invasive cancer. Invasive breast cancer ipsilateral to the treatment disease is considered a recurrence. Data will be recorded regardless of therapy withdrawal after the first dose. Participants without these events at analysis times will be censored at the latest assessment date.
Measured: From enrollment until an event related to EFS occurs, stratified by pCR, assessed up to 5 years
Overall Survival (OS) Stratified by pCR
Measures the time from enrollment to death due to any cause among PET responder participants, stratified by the presence or absence of pathologic complete response (pCR). Participants who have not passed away at the time of analysis will be censored based on the last recorded date when they were known to be alive. Causes of death will be recorded for comprehensive analysis.
Measured: From enrollment until the participant's demise from any cause, assessed up to 5 years
Cardiac Events and Left Ventricular Systolic Dysfunction
Evaluates cardiac events in participants, including symptomatic ejection fraction decrease leading to heart failure (NYHA Class III or IV) with a drop in LVEF of at least 10-percentage points from baseline and below 50%. It also assesses cardiac death rates, distinguishing between definite and probable cardiac deaths. Additionally, it monitors the incidence of asymptomatic or mildly symptomatic left ventricular systolic dysfunction (NYHA Class II), defined by a significant LVEF decrease confirmed by a second assessment within approximately 3 weeks.
Measured: Through study completion, an average of 5 years
Safety - Adverse Events
Monitors clinical and laboratory adverse events (AEs) in participants according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Summarizes AEs and includes previously known adverse events related to the medications in the study, categorized as Adverse Events of Special Interest (AESI) per the defined Adverse Events Definitions.
Measured: Through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start5 Sep 2024
- Primary completionApr 2027 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latin American Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Oncoclínicas
- Responsible party
- Sponsor
- Investigators
- Sérgio Simon, Principal investigator, Oncoclínicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068985
- Sponsor's protocol ID
- LACOG 0721
- Other IDs
- ML44079
- Acronym
- CHERRY-PICK
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade
- ClinicalTrials.gov ID
- NCT06068985
- Acronym / sponsor ID
- CHERRY-PICK / LACOG 0721
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Latin American Cooperative Oncology GroupUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Oncoclínicas
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 5 Oct 2023 (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.
This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy. The approach involves utilizing specific biomarkers (HR and HER2 IHC status) to select participants whose tumors strongly rely on the HER2 pathway, potentially benefiting from a HER2-targeted approach without chemotherapy concurrently.
Detailed description
This is a nonrandomized phase II single arm study to assess de-escalation of chemotherapy in participants with HER2-positive early breast cancer undergoing neoadjuvant therapy with PHESGO™. Participants will be evaluated by central laboratory review for confirmation of selected biomarkers (pre-screening). Participants who meet the biomarker assessment criteria will follow the eligibility criteria assessment. Participants with HER2 positive disease that meet the eligibility criteria will be treated with neoadjuvant PHESGO™.
A baseline PET/CT will be performed prior to start of PHESGO™ treatment. All participants will receive fixed-dose subcutaneous formulation with pertuzumab and trastuzumab (PHESGO™) every 21 days for 3 cycles to evaluate PET/CT response. After the 3rd cycle, participants achieving PET/CT response (defined in this trial as ≥40% reduction in the SUVMax as calculated by the formula SUVbaseline SUVresponse/SUVbaseline) will continue treatment with PHESGO™ for 5 additional cycles, completing 8 neoadjuvant cycles of PHESGO™. Participants without PET/CT response after 3rd cycle will be out of study and will receive treatment and surgery according to institutional standard of care. For this cohort of participant, data regarding treatment received, pCR status and outcomes will be collected.
Definitive breast cancer surgery will be performed after the 8th cycle of therapy. After surgery, participants will receive adjuvant treatment according to their response. Participants achieving pCR will receive PHESGO™ alone as adjuvant treatment to complete a total of one year of therapy, thus receiving 10 cycles of adjuvant PHESGO™. Participants not achieving pCR will receive one of two adjuvant therapy options as per investigator's choice: (1) 14 cycles of trastuzumab emtansine (T-DM1), or (2) investigator's choice chemotherapy regimen (up to 6 cycles) plus 10 cycles of PHESGO™. Disease status and survival data collection will be abstracted from medical records for up to 5 years after surgery.
Participants will be followed for recurrence and survival data with abstraction of data from medical records every 3 months in first year after surgery; every 4 months in second and third years; and then annually until five years. Medical procedures and therapies in the follow-up period are not a formal investigational part of this clinical trial and therefore will be performed according to the institutional standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHESGO™-Based Neoadjuvant Therapy for HER2-Positive Early Breast Cancer | Experimental | Drug: PHESGOThis is a single-arm phase II neoadjuvant study using PHESGO™. Participants will receive three cycles of neoadjuvant PHESGO™, with a specific dosage regimen. After three cycles, participants will be reevaluated based on their PET-CT response. PET-CT response is defined as a ≥40% reduction in SUVMax without metabolic progression in non-target lesions. Responders will receive 5 additional cycles of PHESGO™ before surgery. Non-responders will exit the study, following institutional guidelines. Local surgery follows 8 cycles. Adjuvant therapy varies based on pCR status: 1 year of PHESGO™ for pCR; T-DM1 for 14 cycles or investigator's choice chemotherapy plus 10 additional adjuvant cycles of PHESGO™ for non-pCR cases. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed ICF; Women between 18-80 years of age at time of signing ICF.
- ECOG ≤ 1
- HER2+ breast cancer with clinical stage at presentation: T1cN1, T2, N0-1
- HER2 3+ by IHC, with strongly positive staining for HER2 protein in ≥ 80% of cells, and absence of HER2 negative areas in the tumor
- ER IHC ≤10%
Key exclusion criteria (26 listed)
- Patients with metastatic disease.
- Any previous systemic chemotherapy or anti-HER2 targeted therapy directed to breast cancer.
- Patients with clinical N2 or N3 disease, T4, or inflammatory breast cancer.
- Concurrent serious diseases that may interfere with planned treatment.
- Patients with a history of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years.
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 |
|---|---|---|
| PHESGOSubcutaneous formulation with pertuzumab and trastuzumab. | Drug | PHESGO™-Based Neoadjuvant Therapy for HER2-Positive Early Breast Cancer |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: After eight neoadjuvant cycles of PHESGO™ (each cycle is 21 days)
This outcome measures the rate of participants with HER2-positive early breast cancer who achieve a pathologic complete response (pCR) following neoadjuvant treatment with PHESGO™ without concurrent chemotherapy. Participants selected based on high HER2 pathway dependence and demonstrating a favorable PET-CT response after the third therapy cycle are evaluated for the absence of residual invasive tumor cells in the breast and lymph nodes.
9 secondary outcomes
Rate of Favorable PET-CT Response
Time frame: After three neoadjuvant PHESGO™ cycles (each cycle is 21 days)
Pathologic Response via Residual Cancer Burden (RCB)
Time frame: Immediately after the end of treatment
Objective Response Rate by PERCIST 1.0
Time frame: After three neoadjuvant PHESGO™ cycles (each cycle is 21 days)
Objective Response Rate by RECIST 1.1
Time frame: After eight neoadjuvant cycles of PHESGO™ (each cycle is 21 days)
Invasive Disease-Free Survival (iDFS) Stratified by pCR
Time frame: From enrollment until an event related to invasive disease occurs, stratified by pCR, assessed up to 5 years
Event-Free Survival (EFS) Stratified by pCR
Time frame: From enrollment until an event related to EFS occurs, stratified by pCR, assessed up to 5 years
Overall Survival (OS) Stratified by pCR
Time frame: From enrollment until the participant's demise from any cause, assessed up to 5 years
Cardiac Events and Left Ventricular Systolic Dysfunction
Time frame: Through study completion, an average of 5 years
Safety - Adverse Events
Time frame: Through study completion, an average of 5 years
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 28 Aug 2026.
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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. This study is not recruiting at the moment.
Sérgio Simon principal investigator
Oncoclínicas
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PHESGO in people with Breast Cancer and HER2-positive Breast Cancer, run by Latin American Cooperative Oncology Group at 8 sites 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 11 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: After eight neoadjuvant cycles of PHESGO™ (each cycle is 21 days)). 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 28 Aug 2026.