Breast CancerPhase 2RESPONSENCT05020860
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
A Phase 2 study testing Paclitaxel, Carboplatin and Trastuzumab in people with Breast Cancer and Breast Neoplasm, run by Baylor Breast Care Center at 2 sites in United States.
Trial summary
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasm, Breast Cancer Female
- What is being tested?
- Paclitaxel, Carboplatin and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2023to Nov 2029
- 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
- At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
- Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).
- To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score < 6; 4) Ki-67 ≥ 30%.
- Tumors must be at least 2 cm by clinical exam or ultrasound
- Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
- ECOG performance status of 0 or 1
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- Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
- Adequate organ function, as determined by the following parameters:
- Absolute Neutrophil Count (ANC) ≥ 1200/mm3
- Platelets ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome
- Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
- Serum creatinine ≤ institutional ULN
- The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.
- Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.
Who cannot join
- Definitive clinical or radiologic evidence of Stage IV disease
- Inflammatory breast cancer
- Participants who are pregnant or lactating
- History of an excisional biopsy or lumpectomy performed prior to study entry
- Prior treatment with anthracyclines for any malignancy.
- Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
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- History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:
- Angina pectoris requiring the use of anti-anginal medication
- Ventricular arrhythmias except for benign premature ventricular contractions
- Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
- Conduction abnormality requiring a pacemaker
- Valvular disease with documented compromise in cardiac function
- Symptomatic pericarditis
- Documented cardiomyopathy
- History of documented congestive heart failure (CHF)
- Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.
- Current HIV, hepatitis B, or hepatitis C infection
- History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
- Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.
- Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Harris Health System - Smith Clinic
Houston, Texas, 77054
Maria Rodriguez, 713-798-8347, bcc-clinicalresearch@bcm.edu
Mothaffar Rimawi, MD
- Recruiting
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77054
Maria Rodriguez, 713-798-8347, bcc-clinicalresearch@bcm.edu
Mothaffar Rimawi, MD
About this study
Official title: A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
Read the detailed description
Neoadjuvant therapy was first introduced to improve surgical outcomes of breast cancer and to be able to assess the pathological responsiveness to therapy at the time of surgery. Over time, it became a useful experimental platform in clinical research in breast cancer, and in recent years became an important part of standard management of certain subtypes and clinical stages in breast cancer.
It has been long established that patients who achieve pathologic complete response (pCR, i.e., the absence of any cancer in the tissue removed during surgery) after receiving neoadjuvant treatment have better outcomes than those who don't, especially in HER2+, and triple-negative breast cancer (TNBC). Many reports add aggressive ER+ breast cancer to these groups. So far, the only way to know whether a patient achieved pCR is to give them a full course of therapy and then proceed to surgery.
One of the areas that has attracted significant research interest has been the effort to develop early predictors of pCR. This way, treatment can be tailored in the future to each patient and each tumor and can spare patients ineffective therapy. Some of these predictors include tissue biomarkers, blood based biomarkers, and imaging biomarkers.
It has been observed in neoadjuvant clinical trials that many patients have an impressive early clinical response to treatment after 1-2 cycles of treatment. Anecdotally, many of those patients go on to have a pCR at the time of surgery. This observation, if validated in a prospective clinical trial, may lead to a simple, inexpensive way to assess tumor responsiveness and predict pCR using clinical exam and simple imaging.
Using imaging or molecular changes to predict pCR will also be explored in this study. A consortium of investigators will be studying image analysis and proteogenomic changes early in the course of treatment to predict clinical response specifically in participants with TNBC. Only participants with TNBC will be required to undergo a research biopsy and research MRI prior to starting treatment, and again after the first cycle of treatment.
The investigators therefore hypothesize that absence of early clinical response, defined as at least a 30% reduction in the size of the breast tumor by Day 21 of treatment (as measured by either imaging or clinical exam), will be associated with absence of pCR at the time of surgery, in 3 subtypes of breast cancer - TNBC, HER2+, high-risk ER+.
All treatment in this study is standard of care (non-investigational).
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Paclitaxel, Carboplatin, Trastuzumab, Pertuzumab, Doxorubicin
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle
CarboplatinDrug
Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle
TrastuzumabDrug
Also called Herceptin
Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle
PertuzumabDrug
Also called Perjeta
Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle
DoxorubicinDrug
Also called Adriamycin
60 mg/m2 IV administered on Day 1 of each 14-day cycle
CyclophosphamideDrug
Also called Cytoxan
600 mg/m2 IV administered on Day 1 of each 14-day cycle
PembrolizumabDrug
Also called Keytruda
Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen.
400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.
Pertuzumab/Trastuzumab/Hyaluronidase-zzxfDrug
Also called PHESGO
Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer (for tumors > 5 cm) | Active comparator | Paclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total) Receives: Drug: Paclitaxel; Drug: Carboplatin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Pembrolizumab |
| Triple Negative Breast Cancer (for tumors < 5 cm) | Active comparator | Paclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total) Receives: Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide |
| HER2-Positive Breast Cancer | Active comparator | Paclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total) Receives: Drug: Paclitaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Pertuzumab/Trastuzumab/Hyaluronidase-zzxf |
| Hormone Receptor Positive Breast Cancer | Active comparator | Paclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total) Receives: Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Tumor Measurement vs. Pathologic Response
Clinical tumor measurements are tumor measurements obtain via imaging (mammogram or ultrasound) or by physical exam. Pathologic response is the amount of tumor remaining at the time of surgery, as determined by the pathologist.
Measured: Baseline and at surgery (after 20 weeks)
Secondary outcomes (2)
Pathologic Complete Response Rate in each Breast Cancer Subtype
A pathologic complete response (pCR) means that there is no residual invasive cancer identified in the tissue removed at surgery. The frequency of pCR will be estimated for each breast cancer subtype (triple negative, hormone receptor positive, and HER2-positive)
Measured: 20 weeks
Predictive value of clinical response following 1 cycle of chemotherapy to predict pathologic complete response
This aims to determine whether a 30 percent reduction in tumor size (as measured by physical exam or imaging) following one cycle of chemotherapy can predict whether a patient will have no residual invasive cancer at the time of surgery
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start18 Apr 2023
- Primary completionAug 2027 (estimated)
- Study completionNov 2029 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Breast Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mothaffar Rimawi, Baylor Breast Care Center
- Investigators
- Mothaffar Rimawi, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020860
- Sponsor's protocol ID
- H-50349
- Acronym
- RESPONSE
- Status last verified
- Jan 2025
- First submitted
- 19 Aug 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05020860
- Acronym / sponsor ID
- RESPONSE / H-50349
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive, Breast Cancer Stage II, Breast Cancer Stage III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Baylor Breast Care CenterUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 25 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.
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
Detailed description
Neoadjuvant therapy was first introduced to improve surgical outcomes of breast cancer and to be able to assess the pathological responsiveness to therapy at the time of surgery. Over time, it became a useful experimental platform in clinical research in breast cancer, and in recent years became an important part of standard management of certain subtypes and clinical stages in breast cancer.
It has been long established that patients who achieve pathologic complete response (pCR, i.e., the absence of any cancer in the tissue removed during surgery) after receiving neoadjuvant treatment have better outcomes than those who don't, especially in HER2+, and triple-negative breast cancer (TNBC). Many reports add aggressive ER+ breast cancer to these groups. So far, the only way to know whether a patient achieved pCR is to give them a full course of therapy and then proceed to surgery.
One of the areas that has attracted significant research interest has been the effort to develop early predictors of pCR. This way, treatment can be tailored in the future to each patient and each tumor and can spare patients ineffective therapy. Some of these predictors include tissue biomarkers, blood based biomarkers, and imaging biomarkers.
It has been observed in neoadjuvant clinical trials that many patients have an impressive early clinical response to treatment after 1-2 cycles of treatment. Anecdotally, many of those patients go on to have a pCR at the time of surgery. This observation, if validated in a prospective clinical trial, may lead to a simple, inexpensive way to assess tumor responsiveness and predict pCR using clinical exam and simple imaging.
Using imaging or molecular changes to predict pCR will also be explored in this study. A consortium of investigators will be studying image analysis and proteogenomic changes early in the course of treatment to predict clinical response specifically in participants with TNBC. Only participants with TNBC will be required to undergo a research biopsy and research MRI prior to starting treatment, and again after the first cycle of treatment.
The investigators therefore hypothesize that absence of early clinical response, defined as at least a 30% reduction in the size of the breast tumor by Day 21 of treatment (as measured by either imaging or clinical exam), will be associated with absence of pCR at the time of surgery, in 3 subtypes of breast cancer - TNBC, HER2+, high-risk ER+.
All treatment in this study is standard of care (non-investigational).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer (for tumors > 5 cm) | Active comparator | Drug: Paclitaxel, Drug: Carboplatin, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: PembrolizumabPaclitaxel IV plus carboplatin IV (+/- pembrolizumab IV) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (+/- pembrolizumab IV) (4 cycles total) |
| Triple Negative Breast Cancer (for tumors < 5 cm) | Active comparator | Drug: Paclitaxel, Drug: Doxorubicin, Drug: CyclophosphamidePaclitaxel IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total) |
| HER2-Positive Breast Cancer | Active comparator | Drug: Paclitaxel, Drug: Trastuzumab, Drug: Pertuzumab, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Pertuzumab/Trastuzumab/Hyaluronidase-zzxfPaclitaxel IV plus Trastuzumab IV plus Pertuzumab IV (or PHESGO) (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV administered (4 cycles total) |
| Hormone Receptor Positive Breast Cancer | Active comparator | Drug: Paclitaxel, Drug: Doxorubicin, Drug: CyclophosphamidePaclitaxel IV plus Carboplatin IV (4 cycles total), followed by doxorubicin IV plus cyclophosphamide IV (4 cycles total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
- Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).
- To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score < 6; 4) Ki-67 ≥ 30%.
- Tumors must be at least 2 cm by clinical exam or ultrasound
- Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
Key exclusion criteria (20 listed)
- Definitive clinical or radiologic evidence of Stage IV disease
- Inflammatory breast cancer
- Participants who are pregnant or lactating
- History of an excisional biopsy or lumpectomy performed prior to study entry
- Prior treatment with anthracyclines for any malignancy.
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 |
|---|---|---|
| PaclitaxelAlso: Taxol80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle | Drug | HER2-Positive Breast Cancer, Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer (for tumors < 5 cm), Triple Negative Breast Cancer (for tumors > 5 cm) |
| CarboplatinCarboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle | Drug | Triple Negative Breast Cancer (for tumors > 5 cm) |
| TrastuzumabAlso: HerceptinTrastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle | Drug | HER2-Positive Breast Cancer |
| PertuzumabAlso: PerjetaPertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle | Drug | HER2-Positive Breast Cancer |
| DoxorubicinAlso: Adriamycin60 mg/m2 IV administered on Day 1 of each 14-day cycle | Drug | HER2-Positive Breast Cancer, Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer (for tumors < 5 cm), Triple Negative Breast Cancer (for tumors > 5 cm) |
| CyclophosphamideAlso: Cytoxan600 mg/m2 IV administered on Day 1 of each 14-day cycle | Drug | HER2-Positive Breast Cancer, Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer (for tumors < 5 cm), Triple Negative Breast Cancer (for tumors > 5 cm) |
| PembrolizumabAlso: KeytrudaEither 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen. 400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen. | Drug | Triple Negative Breast Cancer (for tumors > 5 cm) |
| Pertuzumab/Trastuzumab/Hyaluronidase-zzxfAlso: PHESGOCan be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks. | Drug | HER2-Positive Breast Cancer |
Primary outcome
Change in Clinical Tumor Measurement vs. Pathologic Response
Time frame: Baseline and at surgery (after 20 weeks)
Clinical tumor measurements are tumor measurements obtain via imaging (mammogram or ultrasound) or by physical exam. Pathologic response is the amount of tumor remaining at the time of surgery, as determined by the pathologist.
2 secondary outcomes
Pathologic Complete Response Rate in each Breast Cancer Subtype
Time frame: 20 weeks
Predictive value of clinical response following 1 cycle of chemotherapy to predict pathologic complete response
Time frame: 20 weeks
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 27 Feb 2025.
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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.
Mothaffar Rimawi, MD principal investigator
Baylor College of Medicine
2 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 Paclitaxel, Carboplatin and Trastuzumab in people with Breast Cancer and Breast Neoplasm, run by Baylor Breast Care Center at 2 sites 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 17 inclusion and 20 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Maria Rodriguez ((713) 798-8347, bcc-clinicalresearch@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Tumor Measurement vs. Pathologic Response (time frame: Baseline and at surgery (after 20 weeks)). 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 27 Feb 2025.