Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT07407920
Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial
A Phase 2 study testing Biospecimen Collection, Hormone Therapy and Pembrolizumab in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Hormone Therapy and Pembrolizumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 30 Sep 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
- EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor < 10%). The HER2 status (following ASCO/CAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and/or nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology
- FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer [AJCC] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer
- EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel/pertuzumab/trastuzumab [THP]/carboplatin/paclitaxel/pertuzumab/trastuzumab [TCHP] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab
- EARLY TNBC COHORT: Have completed NST with a pembrolizumab plus chemotherapy-based regimen (for example, the KEYNOTE-522 regimen which is paclitaxel plus carboplatin plus pembrolizumab followed by doxorubicin plus cyclophosphamide plus pembrolizumab) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant pembrolizumab
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- The surgical pathology report needs to show a pCR (ypT0-Tis, ypN0) for a patient to be able to participate in this study and all enrolled patients should be willing to discontinue standard adjuvant systemic therapy
- FOR BOTH HER2+ AND TNBC COHORTS: Adequate archival tumor tissue from the core diagnostic biopsy (per Personalis)
- FOR BOTH HER2+ AND TNBC COHORTS: Age ≥ 18 years
- FOR BOTH HER2+ AND TNBC COHORTS: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
- FOR BOTH HER2+ AND TNBC COHORTS: Absolute neutrophil count ≥ 1,000/mcL
- FOR BOTH HER2+ AND TNBC COHORTS: Hemoglobin ≥ 9.0 g/dL
- FOR BOTH HER2+ AND TNBC COHORTS: Platelets ≥ 100,000/mcL
- FOR BOTH HER2+ AND TNBC COHORTS: Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN); patients with Gilbert's syndrome (if direct bilirubin <1.5 x institutional ULN)
- FOR BOTH HER2+ AND TNBC COHORTS: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN
- FOR BOTH HER2+ AND TNBC COHORTS: Creatinine ≤ 1.5 mg/dL
- FOR BOTH HER2+ AND TNBC COHORTS: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- FOR BOTH HER2+ AND TNBC COHORTS: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- FOR BOTH HER2+ AND TNBC COHORTS: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
- FOR BOTH HER2+ AND TNBC COHORTS: Pre- and postmenopausal women are eligible
- FOR BOTH HER2+ AND TNBC COHORTS: Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients with tumor stage of cN2b or cN3 are not eligible
- History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
- Patients who are receiving any other anti-cancer investigational agents
- Patients with known cancer metastases from any site
- Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
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- Blood transfusion within 2 weeks before collection of blood for ctDNA testing
- Patients who have received 4 or more cycles of SOC adjuvant trastuzumab/pertuzumab (HER2+) or 4 or more cycles of SOC adjuvant pembrolizumab (TNBC)
- Pregnant women are not eligible to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Vicente Valero, MD, 713-792-2817, vvalero@mdanderson.org
Vicente Valero, MD
About this study
Official title: Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)
This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the 3-year event free survival (EFS) after breast surgery in patients with early triple negative breast cancer (TNBC) that achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) with a pembrolizumab plus chemotherapy-based regimen and are minimal residual disease (MRD)-negative (negative circulating tumor deoxyribonucleic acid [ctDNA] with the NeXT Personal™ assay) at 4-6 weeks after breast surgery and discontinue standard of care (SOC) adjuvant pembrolizumab.
II. To determine the 3-year EFS after breast surgery in patients with early HER2+ breast cancer that achieve a pCR after NST with a trastuzumab and pertuzumab plus chemotherapy-based regimen and are MRD-negative (negative ctDNA with the NeXT Personal™ assay) at 4-6 weeks after breast surgery and discontinue SOC adjuvant trastuzumab and pertuzumab.
SECONDARY OBJECTIVES:
- To estimate the rate of conversion from negative to positive ctDNA and time to conversion from negative to positive ctDNA among patients who undergo de-escalation of SOC adjuvant systemic therapy.
II. To establish the prevalence of patients with early TNBC or early HER2+ breast cancer who achieve a pCR after receiving NST and have a positive ctDNA with the NeXT Personal™ assay at 4-6 weeks after breast surgery.
III. To determine the 3-year EFS after breast surgery in patients with early HER2+ breast cancer or early TNBC that achieve a pCR after NST and have a positive ctDNA with the NeXT Personal™ assay at 4-6 weeks after breast surgery.
OUTLINE: Patients with triple negative breast cancer are assigned to cohort 1, patients with HER2 positive breast cancer are assigned to cohort 2.
COHORT 1: Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression.
COHORT 2: Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Being tested
- Biospecimen Collection, Hormone Therapy, Pembrolizumab, Pertuzumab, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Hormone TherapyDrug
Also called Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal, Hormonal Therapy
Given standard of care endocrine therapy
PembrolizumabBiological
Also called BCD-201, GME 751, GME751, Keytruda
Given pembrolizumab
PertuzumabBiological
Also called 2C4, 2C4 Antibody, BCD-178, EG1206A
Given pertuzumab
TrastuzumabBiological
Also called ABP 980, ALT02, Biceltis, CANMab
Given trastuzumab
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Triple negative breast cancer) | Experimental | Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Biological: Pembrolizumab |
| Cohort 2 (HER2 positive breast cancer) | Experimental | Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study. Patients undergo blood sample collection throughout the study. Receives: Procedure: Biospecimen Collection; Drug: Hormone Therapy; Biological: Pertuzumab; Biological: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival (EFS)
Will be independently estimated for each cohort, along with corresponding 95% confidence intervals using Kaplan-Meier method.
Measured: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years
Secondary outcomes (4)
Rate of conversion from negative to positive circulating tumor deoxyribonucleic acid (ctDNA)
95% confidence interval will be calculated by cohort using the Clopper-Pearson method.
Measured: Up to 3 years
Time to conversion from negative to positive ctDNA
Will be estimated using the Kaplan-Meier method.
Measured: Up to 3 years
Prevalence of patients with pathologic complete response (pCR) rate after receiving neoadjuvant systemic therapy (NST) and have positive ctDNA
The 95% confidence intervals for the prevalence estimates will be calculated using Clopper-Pearson method.
Measured: At 4-6 weeks after breast surgery
EFS in patients that achieve pCR after NST and have a positive ctDNA
EFS at 3 years with their 95% confidence intervals will be estimated using Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups.
Measured: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Oct 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicente Valero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407920
- Sponsor's protocol ID
- 2024-1206
- Other IDs
- NCI-2025-08252, 2024-1206, P30CA016672
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Adjuvant Systemic Therapy in Patients With Early HER2-Positive (HER2+) Breast Cancer or Triple Negative Breast Cancer (TNBC) That Achieved a Pathological Complete Response (pCR) After Neoadjuvant Systemic Therapy and Do Not Have Molecular Residual Disease (MRD-Negative): A Phase II Clinical Trial (The MolecularPCR Trial)
- ClinicalTrials.gov ID
- NCT07407920
- Acronym / sponsor ID
- 2024-1206
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Early Stage HER2-Positive Breast Carcinoma, Early Stage Triple-Negative Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Feb 2026 (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 phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.
Detailed description
PRIMARY OBJECTIVES:
- To determine the 3-year event free survival (EFS) after breast surgery in patients with early triple negative breast cancer (TNBC) that achieve a pathologic complete response (pCR) after neoadjuvant systemic therapy (NST) with a pembrolizumab plus chemotherapy-based regimen and are minimal residual disease (MRD)-negative (negative circulating tumor deoxyribonucleic acid [ctDNA] with the NeXT Personal™ assay) at 4-6 weeks after breast surgery and discontinue standard of care (SOC) adjuvant pembrolizumab.
II. To determine the 3-year EFS after breast surgery in patients with early HER2+ breast cancer that achieve a pCR after NST with a trastuzumab and pertuzumab plus chemotherapy-based regimen and are MRD-negative (negative ctDNA with the NeXT Personal™ assay) at 4-6 weeks after breast surgery and discontinue SOC adjuvant trastuzumab and pertuzumab.
SECONDARY OBJECTIVES:
- To estimate the rate of conversion from negative to positive ctDNA and time to conversion from negative to positive ctDNA among patients who undergo de-escalation of SOC adjuvant systemic therapy.
II. To establish the prevalence of patients with early TNBC or early HER2+ breast cancer who achieve a pCR after receiving NST and have a positive ctDNA with the NeXT Personal™ assay at 4-6 weeks after breast surgery.
III. To determine the 3-year EFS after breast surgery in patients with early HER2+ breast cancer or early TNBC that achieve a pCR after NST and have a positive ctDNA with the NeXT Personal™ assay at 4-6 weeks after breast surgery.
OUTLINE: Patients with triple negative breast cancer are assigned to cohort 1, patients with HER2 positive breast cancer are assigned to cohort 2.
COHORT 1: Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression.
COHORT 2: Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Triple negative breast cancer) | Experimental | Procedure: Biospecimen Collection, Biological: PembrolizumabPatients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients undergo blood sample collection throughout the study. |
| Cohort 2 (HER2 positive breast cancer) | Experimental | Procedure: Biospecimen Collection, Drug: Hormone Therapy, Biological: Pertuzumab, Biological: TrastuzumabPatients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study. Patients undergo blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor < 10%). The HER2 status (following ASCO/CAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
- FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and/or nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology
- FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer [AJCC] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer
- EARLY HER2+ BREAST CANCER COHORT: Have completed NST with a trastuzumab plus pertuzumab and chemotherapy-based regimen (for example, docetaxel plus minus carboplatin plus trastuzumab plus pertuzumab known as the docetaxel/pertuzumab/trastuzumab [THP]/carboplatin/paclitaxel/pertuzumab/trastuzumab [TCHP] regimens) followed by definitive breast surgery where the surgical pathology reports a pCR (ypT0-Tis, ypN0) and are willing to discontinue adjuvant trastuzumab plus pertuzumab
Key exclusion criteria (9 listed)
- Patients with tumor stage of cN2b or cN3 are not eligible
- History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
- Patients who are receiving any other anti-cancer investigational agents
- Patients with known cancer metastases from any site
- Patients with uncontrolled intercurrent illness including but not limited to active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrythmias
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Cohort 1 (Triple negative breast cancer), Cohort 2 (HER2 positive breast cancer) |
| Hormone TherapyAlso: Chemotherapy-Hormones/Steroids, Endocrine Therapy, Hormonal, Hormonal TherapyGiven standard of care endocrine therapy | Drug | Cohort 2 (HER2 positive breast cancer) |
| PembrolizumabAlso: BCD-201, GME 751, GME751, KeytrudaGiven pembrolizumab | Biological | Cohort 1 (Triple negative breast cancer) |
| PertuzumabAlso: 2C4, 2C4 Antibody, BCD-178, EG1206AGiven pertuzumab | Biological | Cohort 2 (HER2 positive breast cancer) |
| TrastuzumabAlso: ABP 980, ALT02, Biceltis, CANMabGiven trastuzumab | Biological | Cohort 2 (HER2 positive breast cancer) |
Primary outcome
Event free survival (EFS)
Time frame: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years
Will be independently estimated for each cohort, along with corresponding 95% confidence intervals using Kaplan-Meier method.
4 secondary outcomes
Rate of conversion from negative to positive circulating tumor deoxyribonucleic acid (ctDNA)
Time frame: Up to 3 years
Time to conversion from negative to positive ctDNA
Time frame: Up to 3 years
Prevalence of patients with pathologic complete response (pCR) rate after receiving neoadjuvant systemic therapy (NST) and have positive ctDNA
Time frame: At 4-6 weeks after breast surgery
EFS in patients that achieve pCR after NST and have a positive ctDNA
Time frame: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 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 24 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Vicente Valero, MD principal investigator
M.D. Anderson 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 Biospecimen Collection, Hormone Therapy and Pembrolizumab in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.
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 21 inclusion and 9 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 24 Sep 2026. 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 United States. 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 Vicente Valero, MD ((713) 563-0751, vvalero@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (EFS) (time frame: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years). 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 24 Sep 2026.