Triple-negative Breast CancerNCT04362462
Molecular Profiling After Neoadjuvant Chemotherapy for Triple-negative Breast Cancer
An observational study of Triple-negative Breast Cancer, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Neoadjuvant chemotherapy (NACT) can induce complete pathologic response (pCR) in approximately 35-55% of patient with triple-negative breast cancer (TNBC). These patients have excellent long term survivals. On the other hand patients with residual disease exhibit a high rate of local or metastatic. Read more about this study
- Who is it for?
- Ages 18 to 86 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 86 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females with confirmed triple-negative breast cancer.
Who may be able to join
- Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).
- Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).
- Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.
- All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.
Who cannot join
- Women < 18 or >86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Texas Tech University Health Sciences Center- El Paso
El Paso, Texas, 79905
Alexander Philipovskiy, MD, PhD, 915-215-5195, alexander.philipovskiy@ttuhsc.edu
Brenda Castillo, BS, 9152154831, brenda.castillo@ttuhsc.edu
About this study
Official title: Genomic/Molecular Profiling of Residual Disease After Neoadjuvant Chemotherapy in Hispanic/ Latino Women With Triple-negative Breast Cancer
Neoadjuvant chemotherapy (NACT) can induce complete pathologic response (pCR) in approximately 35-55% of patient with triple-negative breast cancer (TNBC). These patients have excellent long term survivals. On the other hand patients with residual disease exhibit a high rate of local or metastatic. Although it has been successful in some regards, randomized trials have shown similar rates of mortality between patients receiving NACT and adjuvant chemotherapy (ACT). The goal of this study is to understand the molecular biology (gene expression signature) driving treatment-resistant TNBC. The investigators are planning to identify targetable genetic alterations which may help to optimize adjuvant therapy for the patient with residual TNBC.
Read the detailed description
In this study, investigators will understand the clinical relevance of genomic heterogeneity of triple-negative breast cancer by determining pathological complete response (pCR) rates after NACT, based on genomic profiling of individual tumors. Investigators will identify new genomic alterations in patients with residual TNBC as well as in patients who develop metastatic disease within 24 months after completion of all appropriate therapies. Investigators will demonstrate unique genomic alteration, and we will identify new tumor markers in Hispanic/Latino (H/L) women with TNBC.
Inclusion Criteria:
This study aims to include all patients with early stage (I-III) TNBC who received NACT and subsequently underwent surgical treatment (mastectomy or lumpectomy) or women with triple-negative breast cancer who progressed and developed metastatic disease within 24 months after all appropriate therapies.
- Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).
- Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).
- Patients must be eligible for NACT, and surgical lumpectomy or mastectomy.
- All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.
Exclusion Criteria:
- Women < 18 or >86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
- Conditions
- Triple-negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival at one and two years in order to avoid unnecessary chemotherapy in patients with chemotherapy resistant tumors. We will measure and track the response rate to chemotherapy as well as pathological complete response after chemotherapy.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start5 Mar 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Philipovskiy, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Alexander Philipovskiy, MD, PhD, Principal investigator, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362462
- Sponsor's protocol ID
- E19059
- Status last verified
- Apr 2020
- First submitted
- 18 Dec 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic/Molecular Profiling of Residual Disease After Neoadjuvant Chemotherapy in Hispanic/ Latino Women With Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04362462
- Acronym / sponsor ID
- E19059
- Conditions
- Triple-negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Apr 2020 (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.
Neoadjuvant chemotherapy (NACT) can induce complete pathologic response (pCR) in approximately 35-55% of patient with triple-negative breast cancer (TNBC). These patients have excellent long term survivals. On the other hand patients with residual disease exhibit a high rate of local or metastatic. Although it has been successful in some regards, randomized trials have shown similar rates of mortality between patients receiving NACT and adjuvant chemotherapy (ACT). The goal of this study is to understand the molecular biology (gene expression signature) driving treatment-resistant TNBC. The investigators are planning to identify targetable genetic alterations which may help to optimize adjuvant therapy for the patient with residual TNBC.
Detailed description
In this study, investigators will understand the clinical relevance of genomic heterogeneity of triple-negative breast cancer by determining pathological complete response (pCR) rates after NACT, based on genomic profiling of individual tumors. Investigators will identify new genomic alterations in patients with residual TNBC as well as in patients who develop metastatic disease within 24 months after completion of all appropriate therapies. Investigators will demonstrate unique genomic alteration, and we will identify new tumor markers in Hispanic/Latino (H/L) women with TNBC.
Inclusion Criteria:
This study aims to include all patients with early stage (I-III) TNBC who received NACT and subsequently underwent surgical treatment (mastectomy or lumpectomy) or women with triple-negative breast cancer who progressed and developed metastatic disease within 24 months after all appropriate therapies.
- Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).
- Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).
- Patients must be eligible for NACT, and surgical lumpectomy or mastectomy.
- All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.
Exclusion Criteria:
- Women < 18 or >86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 86 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females with confirmed triple-negative breast cancer.
Key inclusion criteria (4 listed)
- Age > 18 or <86 years of age, for Hispanic/Latino women we will use the National Advisory Committee on Racial, Ethnic and Other populations NAC definition which is (the ethnonyms "Hispanic" and "Latino" to refer collectively to the inhabitants of the United States of America who are of Latin American or Spanish origin-that is, Latino or Hispanic Americans).
- Pre- and Post - menopausal women with histologically confirmed hormonal receptor negative (ER and/or PR <1%), Her2-neu - negative (by IHC or/and FISH) invasive breast cancer stages I - III or with metastatic triple-negative breast cancer (if develop metastatic disease during the chemotherapy or within 24 months after completion of all appropriate treatments).
- Patient must be eligible for neo-adjuvant chemotherapy, and surgical lumpectomy or mastectomy.
- All patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with Institutional and Federal guidelines.
Key exclusion criteria (2 listed)
- Women < 18 or >86 years of age
- ER/PR- positive, Her-2 neu - positive breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival
Time frame: 12-24 months
Progression free survival at one and two years in order to avoid unnecessary chemotherapy in patients with chemotherapy resistant tumors. We will measure and track the response rate to chemotherapy as well as pathological complete response after chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
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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.
Alexander Philipovskiy, MD, PhD principal investigator
Texas Tech University Health Sciences Center, El Paso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple-negative Breast Cancer, run by Texas Tech University Health Sciences Center, El Paso 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 27 Apr 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Philipovskiy, MD, PhD (9158155195, alexander.philipovskiy@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 12-24 months). 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 Apr 2020.