Breast CancerNCT01850628
NSABP Biospecimen Discovery Project
An observational study of Breast Cancer, run by NSABP Foundation Inc at 5 sites in United States.
Trial summary
This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel, trastuzumab and pertuzumab
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2013to Feb 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with locally advanced, HER2-positive breast cancer from selected sites in the United States
Who may be able to join
- The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
- The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.
- The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy.
- Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator.
Who cannot join
- Excisional biopsy or lumpectomy performed prior to registration.
- Previous therapy with chemotherapy or targeted therapy for any malignancy.
- Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration.
- Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Florida
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
New York University School of Medicine
New York, New York, 10016
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.
Read the detailed description
This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (MS) based and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. The study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, trastuzumab, pertuzumab
- Keywords
- National Surgical Adjuvant Breast and Bowel Project (NSABP), paclitaxel, trastuzumab, pertuzumab, HER2 positive (human epidermal growth factor receptor 2), Proteomics, Neoadjuvant Therapy, Anthracycline therapy, Locally advanced, Operable, Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
trastuzumabBiological
Also called Herceptin
pertuzumabBiological
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel plus trastuzumab or trastuzumab/pertuzumab | Patient received paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination administered per investigators discretion Receives: Drug: Paclitaxel; Biological: trastuzumab; Biological: pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination
Measured: blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2018
- Study completionFeb 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- Breast Cancer Research Foundation, Washington University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850628
- Sponsor's protocol ID
- NSABP DP-1
- Status last verified
- Oct 2021
- First submitted
- 1 May 2013
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSABP Biospecimen Discovery Project
- ClinicalTrials.gov ID
- NCT01850628
- Acronym / sponsor ID
- NSABP DP-1
- Conditions
- Breast Cancer
- Keywords
- National Surgical Adjuvant Breast and Bowel Project (NSABP), paclitaxel, trastuzumab, pertuzumab, HER2 positive (human epidermal growth factor receptor 2), Proteomics, Neoadjuvant Therapy, Anthracycline therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- Breast Cancer Research Foundation, Washington University School of Medicine
- Study start
- Jul 2013
- Primary completion
- Jun 2018 (actual)
- Study completion
- Feb 2022 (estimated)
- First posted
- 9 May 2013 (estimated)
- 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 is a biospecimen discovery project that will serve as a pilot for a comprehensive 'omics approach using fresh core biopsy tissue and blood samples for DNA and protein analysis, as well as paired tumor-normal exome DNA and RNA sequencing.
Detailed description
This study will be conducted at select NSABP sites where investigators are willing to give paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination as the initial component of neoadjuvant therapy as a pilot for a comprehensive 'omics approach using next generation sequencing and protein expression and post-translational modification analysis using mass spectrometry (MS) based and Reverse Phase Protein Array-based proteomics. Tumor samples will be obtained at baseline and 48 to 72 hours after initial drug treatment to study variation in the biological responses to these agents. The study of tumors both before and early after the first treatment probes the biological responses to treatment and is rich source of predictive biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel plus trastuzumab or trastuzumab/pertuzumab | – | Drug: Paclitaxel, Biological: trastuzumab, Biological: pertuzumabPatient received paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination administered per investigators discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with locally advanced, HER2-positive breast cancer from selected sites in the United States
Key inclusion criteria (4 listed)
- The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
- The breast cancer must be HER2-positive based on current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer.
- The patient must have a mass in the breast measuring greater than or equal to 2.0 cm by physical exam and/or ultrasound that is accessible and safe for repeat biopsy. Patients with a diagnosis of inflammatory breast cancer are eligible if there is a palpable or detectable breast mass that is accessible and safe for repeat biopsy.
- Planned initial treatment with a combination of paclitaxel and trastuzumab or a trastuzumab/pertuzumab-based combination. Schedule for paclitaxel/trastuzumab or trastuzumab/pertuzumab administration is per the investigator.
Key exclusion criteria (4 listed)
- Excisional biopsy or lumpectomy performed prior to registration.
- Previous therapy with chemotherapy or targeted therapy for any malignancy.
- Treatment, including radiation therapy (RT), chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to registration.
- Other nonmalignant systemic disease that would preclude the patient from receiving chemotherapy and targeted therapy.
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 |
|---|---|---|
| Paclitaxel | Drug | Paclitaxel plus trastuzumab or trastuzumab/pertuzumab |
| trastuzumabAlso: Herceptin | Biological | Paclitaxel plus trastuzumab or trastuzumab/pertuzumab |
| pertuzumab | Biological | Paclitaxel plus trastuzumab or trastuzumab/pertuzumab |
Primary outcome
Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination
Time frame: blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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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.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NSABP Foundation Inc at 5 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 4 inclusion and 4 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
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?
Measure variation in biologic response by comprehensive tumor 'omics profiling in patients receiving an upfront regimen containing paclitaxel plus trastuzumab or a trastuzumab/pertuzumab-based combination (time frame: blood and tissue specimens will be collected at the time of diagnosis; prior to treatment; 48 and 72 hours following first dose of treatment; and following surgery, if tumor remains.). 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 5 Oct 2021.