Breast CancerPhase 2NCT02280252
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
A Phase 2 study testing Paclitaxel and Radiation therapy in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. 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 and Radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to 20 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
- Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
- Measureable disease required
- Adequate laboratory values:
- Hgb > 10 ANC > 1500 Platelets > 150,000 Creatinine < 1.5 Liver function < 3x normal
- Patient ≥ 18 years of age
Show all 11Show fewer
- Medically and psychologically able to comply with all study requirements
- ECOG performance score 0-1
- CT chest, abdomen, and pelvis performed
- Mammogram or USG performed
- Signed informed consent
Who cannot join
- Breast cancer patients with Stage 0, Stage I, or Stage IIA
- Previous XRT or chemotherapy
- Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
- Pregnancy
- Inflammatory breast cancer
- Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
- Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites)
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.
Read the detailed description
The term -locally advanced breast cancer (LABC) commonly includes tumors whose maximum diameter is 5 cm (T3) or larger, or which present with involvement of the chest wall or skin. Surprisingly, the simultaneous presence of clinically detectable distant metastases is relatively infrequent (~8%), a peculiar finding since in 73% of these large tumors it is possible to document shedding of tumor cells into the blood.
While LABC has become a rare clinical presentation of breast cancer in the general population as a result of improved early detection by mammographic screening, it remains relatively common among minority women of low socioeconomic status. For instance, in a consecutive series of 363 African-American women presenting in a large urban hospital, one out of three women newly diagnosed with breast cancer had LABC.
It is well documented that although the incidence of breast cancer among African-Americans is lower than among white women, breast cancer mortality in African-Americans is significantly higher. In 1998, the American Cancer Society, the National Cancer Institute and the Centers for Disease Control and Prevention reported an overall downward trend in cancer incidence and mortality between 1990 and 1995 for all cancers combined. Many minority and medically underserved populations, however, did not share equally in these improvements. These patients have continued to encounter multifactorial barriers to early detection and care, warranting interventions to improve access.
At the same time, it is equally important to offer the best chance for survival to those underserved women who have already availed themselves of medical care. Paradoxically, while the medical community is aware of the inadequate accrual of minority patients to clinical trials, only few trials exist for LABC.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, Radiation therapy
- Keywords
- Locally-advanced Breast Cancer, LABC, breast cancer, breast, cancer, metastasis, metastatic, tumor, radiation, radiation therapy, radiotherapy, paclitaxel
- Medical subject headings
- Breast Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Abraxane
Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.
Radiation therapyRadiation
Also called radiotherapy
Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Paclitaxel and RT | Experimental | Patients will be administered pre-operatively over 12 weeks either:
1. Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule
2. Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule
Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7:
Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions) Receives: Drug: Paclitaxel; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort
Test the effectiveness of concurrent paclitaxel and radiation in a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. Local recurrence, regional recurrence and overall survival will be measured
Measured: 4.5 years
Secondary outcomes (3)
Measure the Pathological Response Rate of Concurrent Paclitaxel-radiation
Measure the pathological response rate to concurrent paclitaxel-radiation at each collaborating institution and compare it to that achieved in a previous Phase I-II trial
Measured: 4.5 years
Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer
Obtain core biopsies of the original tumor before and after treatment (from the surgical specimen) for molecular biology and genomic studies of biomarkers and genetic anomalies that may signal a population's predisposition to breast cancer and/or susceptibility to study intervention
Measured: 4.5 years
Patient Demographics
Acquire descriptive information on patient epidemiological, cultural and behavioral characteristics
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2005
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly Huppert, M.D., Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280252
- Sponsor's protocol ID
- 06-209
- Status last verified
- Nov 2020
- First submitted
- 8 Oct 2014
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation
- ClinicalTrials.gov ID
- NCT02280252
- Acronym / sponsor ID
- 06-209
- Conditions
- Breast Cancer
- Keywords
- Locally-advanced Breast Cancer, LABC, breast cancer, breast, cancer, metastasis, metastatic, tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.
Detailed description
The term -locally advanced breast cancer (LABC) commonly includes tumors whose maximum diameter is 5 cm (T3) or larger, or which present with involvement of the chest wall or skin. Surprisingly, the simultaneous presence of clinically detectable distant metastases is relatively infrequent (~8%), a peculiar finding since in 73% of these large tumors it is possible to document shedding of tumor cells into the blood.
While LABC has become a rare clinical presentation of breast cancer in the general population as a result of improved early detection by mammographic screening, it remains relatively common among minority women of low socioeconomic status. For instance, in a consecutive series of 363 African-American women presenting in a large urban hospital, one out of three women newly diagnosed with breast cancer had LABC.
It is well documented that although the incidence of breast cancer among African-Americans is lower than among white women, breast cancer mortality in African-Americans is significantly higher. In 1998, the American Cancer Society, the National Cancer Institute and the Centers for Disease Control and Prevention reported an overall downward trend in cancer incidence and mortality between 1990 and 1995 for all cancers combined. Many minority and medically underserved populations, however, did not share equally in these improvements. These patients have continued to encounter multifactorial barriers to early detection and care, warranting interventions to improve access.
At the same time, it is equally important to offer the best chance for survival to those underserved women who have already availed themselves of medical care. Paradoxically, while the medical community is aware of the inadequate accrual of minority patients to clinical trials, only few trials exist for LABC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concurrent Paclitaxel and RT | Experimental | Drug: Paclitaxel, Radiation: Radiation therapyPatients will be administered pre-operatively over 12 weeks either: 1. Paclitaxel, 30mg/m^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule 2. Abraxane, 30mg/m^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7: Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
- Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
- Measureable disease required
- Adequate laboratory values:
- Hgb > 10 ANC > 1500 Platelets > 150,000 Creatinine < 1.5 Liver function < 3x normal
Key exclusion criteria (7 listed)
- Breast cancer patients with Stage 0, Stage I, or Stage IIA
- Previous XRT or chemotherapy
- Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
- Pregnancy
- 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 |
|---|---|---|
| PaclitaxelAlso: AbraxanePaclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule. | Drug | Concurrent Paclitaxel and RT |
| Radiation therapyAlso: radiotherapyPatients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions) | Radiation | Concurrent Paclitaxel and RT |
Primary outcome
Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort
Time frame: 4.5 years
Test the effectiveness of concurrent paclitaxel and radiation in a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. Local recurrence, regional recurrence and overall survival will be measured
3 secondary outcomes
Measure the Pathological Response Rate of Concurrent Paclitaxel-radiation
Time frame: 4.5 years
Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer
Time frame: 4.5 years
Patient Demographics
Time frame: 4.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nelly Huppert, M.D. principal investigator
NYU Langone Medical 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 Paclitaxel and Radiation therapy in people with Breast Cancer, run by NYU Langone Health 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 11 inclusion and 7 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: finished, as of the sponsor's last update on 23 Nov 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.
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?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort (time frame: 4.5 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 23 Nov 2020.