Breast CancerPT-304NCT01007890
Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer
An observational study of Breast Cancer, run by Precision Therapeutics at 28 sites in United States.
Trial summary
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. 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?
- ChemoFX Assay
- How many people
- 134 participants
- Where
- 28 sitesUnited States
- Study dates
- Nov 2009to Oct 2012
- 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 18 years or older with Palpable Operable Breast Cancer Measurable Disease
Who may be able to join
- Female subjects who satisfy the following conditions will be considered for enrollment into the study:
- The subject must consent to be in the research study and must have signed an approved consent form conforming to institutional guidelines prior to study entry.
- The diagnosis of breast cancer can be made by FNA or biopsy (other than incisional or excisional). The tumor specimen must demonstrate a diagnosis of invasive adenocarcinoma.
- The primary breast cancer must be operable and measurable "greater than or equal to" 2.0 cm by use of physical exam and/or ultrasound, MRI, CT scan, or mammogram.
- T1c, T2, T3, or T4 patients clinically staged as M0 (non-inflammatory) are eligible.
- Patients with a prior diagnosis and treatment for DCIS are eligible.
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- Patients with multi-focal breast cancer are eligible.
- The tumor must be confined to either the breast or to the breast and ipsilateral axilla.
- The subject must be 18 years or older.
- The interval between initial cytologic or histologic diagnosis of breast cancer and registration must be no more than 10 weeks.
- ECOG Performance Status of 0 or 1 (see Appendix A) is required.
- The subject must receive standard of care chemotherapy regimens consisting of either doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or nab-paclitaxel administered in any sequence and combination the treating physician determines or docetaxel (T) plus cyclophosphamide (C).
Who cannot join
- Male subjects are not eligible for this study as the incidence of breast cancer in male subjects is significantly lower than female subjects. Those subjects who are strongly HER2-positive will be excluded as they will require treatment by biological agents for which the ChemoResponse Assay has not yet been validated. Subjects with evidence of distant metastatic disease are excluded as these subjects would not be good candidates for neoadjuvant therapy. Women who have had an excisional or incisional biopsy prior to entry would not have sufficient tumor sample to test or to be measured by physical exam for the study. Women who have nonmalignant comorbid conditions and diseases that would preclude them from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study are also excluded. Women with psychiatric or addictive disorders are excluded to protect those vulnerable subjects who may not be able to adequately give informed consent.
- Women with one or more of the following conditions will be ineligible for this study:
- Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification)
- Definitive clinical or radiologic evidence of distant metastatic disease.
- Excisional or incisional biopsy for this primary breast tumor.
- Inflammatory breast cancer.
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- Synchronous contra-lateral breast cancer.
- Multi-centric breast cancer.
- Participation in the NSABP B-40 study.
- Prior therapy for invasive breast cancer, including irradiation, chemo-, immuno-, and/or hormonal therapy.
- Note: the only exception is hormonal therapy, which may have been given anytime after diagnosis and before study entry as long as the hormonal therapy is discontinued at or before registration. After surgery, hormonal therapy may be re-started, at the discretion of the treating physician.
- Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention, or sex hormonal therapy such as birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible IF these medications are discontinued prior to registration.
- Surgical axillary staging procedure prior to study entry.
- Note: exceptions include FNA of an axillary node and pre-neoadjuvant sentinel lymph node biopsy for patients with clinically negative axillary nodes.
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the woman from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study.
- Psychiatric or addictive disorders that would preclude obtaining informed consent.
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Breast Care Specialists, P.C.
Allentown, Pennsylvania, 18104
Texas Oncology - Bedford
Bedford, Texas, 76022
Missouri Cancer Associates
Columbia, Missouri, 65201
Dallas Surgical Group
Dallas, Texas, 75230
Leading Edge Research, PA
Dallas, Texas, 75230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Breast Clinic of Memphis
Germantown, Tennessee, 38138
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074
Texas Oncology - Memorial City
Houston, Texas, 77024
Breast Care
Las Vegas, Nevada, 89106
Breastlink Medical Group, Inc
Long Beach, California, 90806
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Advanced Breast Care
Marietta, Georgia, 30060
Advanced Medical Specialties
Miami, Florida, 33176
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
Morristown Memorial Hospital
Morristown, New Jersey, 07962
Advantage Clinical Research
Nashville, Tennessee, 37203
Tennessee Breast Specialists
Nashville, Tennessee, 37203
Beth Israel Medical Center
New York, New York, 10003
Virginia Oncology Associates
Norfolk, Virginia, 23502
OU Medical Center
Oklahoma City, Oklahoma, 73104
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Women & Infants Hospital
Providence, Rhode Island, 02905
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Southlake Oncology
Southlake, Texas, 76092
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477
Texas Oncology - Tyler
Tyler, Texas, 75702
About this study
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.
Read the detailed description
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. The anticipated biomarker will take into account clinical factors (such as tumor stage, tumor size, and age), phenotypic characteristics of the tumor (determined by pathological immunohistochemistry and ex vivo ChemoResponse assay), and genotypic characteristics of the tumor and patient (determined by genomic profiling via gene expression analysis of tumor RNA). It is expected that collective consideration of all of these factors will be more predictive of patient response to therapy than any of them alone.
Approximately 224 evaluable subjects will be recruited from approximately 30 US sites. Women with measurable operable invasive breast cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of chemotherapy via core needle biopsies to be used for the ex vivo ChemoResponse Assay and tumor genomic analysis (gene expression), respectively.
All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents: doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or Abraxane (nanoparticle albumin-bound paclitaxel [nab-paclitaxel]); or, docetaxel (T) and cyclophosphamide (C). These must be administered per NCCN guidelines by the treating physician.
Upon completion of chemotherapy treatment, women will undergo lumpectomy, modified radical mastectomy or other surgical procedure determined appropriate by the investigator and at that time will be evaluated for pathological response. At the time of lumpectomy, modified radical mastectomy, or other surgical procedure, additional tumor excess will be sent to Precision Therapeutics, Inc. (Precision) for exploratory analysis if there is no pathologic complete response (pCR), if there are sufficient tumor cells to send, and if the patient agrees to have her excess tumor cells sent to Precision for this purpose.
During the patient's course of participation on the study, the treating physician will remain blinded to the results of the ChemoResponse Assay and genomic analysis. If it is determined there is no pCR at the time of lumpectomy, modified radical mastectomy or other surgical procedure, Precision will make available a subsequent report to the physician containing additional information about chemotherapy drugs other than ACT that could benefit the further treatment decisions for the patient.
- Conditions
- Breast Cancer
- Being tested
- ChemoFX Assay
- Keywords
- ChemoFX, Operable, Breast, Cancer, Measurable, Disease
- Medical subject headings
- Breast Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoFX AssayOther
Test of an algorithm to predict pathologic response in patients treated with neoadjuvant chemotherapy for breast cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
Measured: 24 months
Secondary outcomes (1)
Secondary clinical endpoint cOR will be an ordinal outcome variable with complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) four levels.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completionOct 2012
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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Darrell Lis, RN, MSN, Study director, Precision Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007890
- Sponsor's protocol ID
- PT-304
- Acronym
- PT-304
- Status last verified
- Oct 2012
- First submitted
- 3 Nov 2009
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT01007890
- Acronym / sponsor ID
- PT-304 / PT-304
- Conditions
- Breast Cancer
- Keywords
- ChemoFX, Operable, Breast, Cancer, Measurable, Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Precision TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- Nov 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Nov 2009 (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.
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.
Detailed description
The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. The anticipated biomarker will take into account clinical factors (such as tumor stage, tumor size, and age), phenotypic characteristics of the tumor (determined by pathological immunohistochemistry and ex vivo ChemoResponse assay), and genotypic characteristics of the tumor and patient (determined by genomic profiling via gene expression analysis of tumor RNA). It is expected that collective consideration of all of these factors will be more predictive of patient response to therapy than any of them alone.
Approximately 224 evaluable subjects will be recruited from approximately 30 US sites. Women with measurable operable invasive breast cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of chemotherapy via core needle biopsies to be used for the ex vivo ChemoResponse Assay and tumor genomic analysis (gene expression), respectively.
All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents: doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or Abraxane (nanoparticle albumin-bound paclitaxel [nab-paclitaxel]); or, docetaxel (T) and cyclophosphamide (C). These must be administered per NCCN guidelines by the treating physician.
Upon completion of chemotherapy treatment, women will undergo lumpectomy, modified radical mastectomy or other surgical procedure determined appropriate by the investigator and at that time will be evaluated for pathological response. At the time of lumpectomy, modified radical mastectomy, or other surgical procedure, additional tumor excess will be sent to Precision Therapeutics, Inc. (Precision) for exploratory analysis if there is no pathologic complete response (pCR), if there are sufficient tumor cells to send, and if the patient agrees to have her excess tumor cells sent to Precision for this purpose.
During the patient's course of participation on the study, the treating physician will remain blinded to the results of the ChemoResponse Assay and genomic analysis. If it is determined there is no pCR at the time of lumpectomy, modified radical mastectomy or other surgical procedure, Precision will make available a subsequent report to the physician containing additional information about chemotherapy drugs other than ACT that could benefit the further treatment decisions for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women 18 years or older with Palpable Operable Breast Cancer Measurable Disease
Key inclusion criteria (12 listed)
- Female subjects who satisfy the following conditions will be considered for enrollment into the study:
- The subject must consent to be in the research study and must have signed an approved consent form conforming to institutional guidelines prior to study entry.
- The diagnosis of breast cancer can be made by FNA or biopsy (other than incisional or excisional). The tumor specimen must demonstrate a diagnosis of invasive adenocarcinoma.
- The primary breast cancer must be operable and measurable "greater than or equal to" 2.0 cm by use of physical exam and/or ultrasound, MRI, CT scan, or mammogram.
- T1c, T2, T3, or T4 patients clinically staged as M0 (non-inflammatory) are eligible.
Key exclusion criteria (16 listed)
- Male subjects are not eligible for this study as the incidence of breast cancer in male subjects is significantly lower than female subjects. Those subjects who are strongly HER2-positive will be excluded as they will require treatment by biological agents for which the ChemoResponse Assay has not yet been validated. Subjects with evidence of distant metastatic disease are excluded as these subjects would not be good candidates for neoadjuvant therapy. Women who have had an excisional or incisional biopsy prior to entry would not have sufficient tumor sample to test or to be measured by physical exam for the study. Women who have nonmalignant comorbid conditions and diseases that would preclude them from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study are also excluded. Women with psychiatric or addictive disorders are excluded to protect those vulnerable subjects who may not be able to adequately give informed consent.
- Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification)
- Definitive clinical or radiologic evidence of distant metastatic disease.
- Excisional or incisional biopsy for this primary breast tumor.
- Inflammatory 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoFX AssayTest of an algorithm to predict pathologic response in patients treated with neoadjuvant chemotherapy for breast cancer. | Other | – |
Primary outcome
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
Time frame: 24 months
1 secondary outcome
Secondary clinical endpoint cOR will be an ordinal outcome variable with complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) four levels.
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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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.
Darrell Lis, RN, MSN study director
Precision Therapeutics
28 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 Precision Therapeutics at 28 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 12 inclusion and 16 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: stopped early, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
The study was stopped early. 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?
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response. (time frame: 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 5 Oct 2012.