Breast CancerNCT01159236
Molecular Triaging of Newly Diagnosed Breast Cancer
A study testing Paclitaxel, Fluorouracil and Doxorubicin in people with Breast Cancer, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery. 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, Fluorouracil and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to not given
- Phase
- Interventional
- 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
Who may be able to join
- Patients 18 years of age or older with histologically confirmed HER2-normal (defined as fluorescence in situ hybridization, FISH < 2.2 or immunohistochemistry, IHC <3+ if FISH result is not available) invasive carcinoma of the breast for whom systemic adjuvant therapy is clinically indicated.
- Patients must have intact cancer in the breast and intact regional lymph nodes (diagnostic core needle or fine needle biopsies are allowed).
- Routine estrogen, progesterone and HER-2 receptor determination must be performed before starting therapy.
- Patients with prior history of breast cancer are eligible.
- Patients with bilateral breast cancers are eligible.
- Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of starting chemotherapy. Patients must agree to barrier contraception (condom) while on study.
- Patients must agree to undergo pretreatment needle biopsy of the primary tumor in the breast for molecular profiling.
- Patients must agree to undergo surgery at MDACC and if assigned to bevacizumab containing chemotherapy it must be administered at MDACC.
Who cannot join
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, including: uncompensated congestive heart failure, myocardial infarction within the past 12 months, pre-existing peripheral neuropathy > grade 2, prior doxorubicin therapy with > cumulative dose of 240 mg/m^2
- Women who had lumpectomy or surgical partial excisional biopsy of the cancer, or sentinel lymph node biopsy of a positive node, before starting preoperative therapy.
- Exclusion criteria for bevacizumab therapy; inadequately controlled hypertension (defined as systolic blood pressure >/= 140 mmHg and/or diastolic blood pressure >/= 90 mmHg).
- Exclusion criteria for bevacizumab therapy, prior history of hypertensive crisis or hypertensive encephalopathy, stroke or transient ischemic attacks.
- Exclusion criteria for bevacizumab therapy, history of myocardial infarction, unstable angina or congestive heart failure within 12 months prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis within 6 months prior to starting therapy.
Show all 11Show fewer
- Exclusion criteria for bevacizumab therapy, history of hemoptysis ( 1/2 teaspoon of bright red blood per episode) within 1 month prior to starting therapy or evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
- Exclusion criteria for bevacizumab therapy. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting therapy or core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, history of abdominal fistula or gastrointestinal perforation within 6 months prior to starting therapy.
- Exclusion criteria for bevacizumab therapy, serious, non-healing wound or fracture or active ulcer.
- Proteinuria within 1 months of starting therapy as demonstrated by either (a) Urine protein:creatinine (UPC) ratio >/= 1.0 or (b) proteinuria >/= 2+ by urine dipstick test. Patients discovered to have >/=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate </= 1g of protein in 24 hours to be eligible.
About this study
Official title: Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies
The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.
Read the detailed description
At this time, treatment of stage I-III breast cancer for patients who are at high risk for the cancer returning is surgery and chemotherapy. If the cancer is positive for estrogen hormone receptor, patients also have endocrine therapy.
The most common standard chemotherapy treatment regimens for breast cancer at M. D. Anderson are paclitaxel (T), followed by treatments with fluorouracil (F), doxorubicin (A) or epirubicin (E), and cyclophosphamide (C). These chemotherapy combinations are known as T/FAC and T/FEC. However, not all patients respond to these treatments, so researchers at M. D. Anderson have developed tests to predict how much a person's breast cancer might respond to T/FAC or T/FEC chemotherapy.
Fine needle aspiration (FNA) of the tumor are collected after numbing the skin of the breast with local anesthesia, and the genes within the FNA sample are measured to calculate the results of treatment prediction tests before treatment is selected.
In this research study, the gene-based tests will help to select treatment based on the predictions of response to chemotherapy, and to then measure the tumor response from the surgery after the treatment.
Study Drugs:
T/FAC and T/FEC are designed to damage the DNA (genetic material of cells), which may cause cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells and make them more susceptible to chemotherapy.
Tumor Biopsies:
If you are found eligible to take part in this study, you will have 3-4 fine needle biopsies of the tumor collected. The skin over the tumor and the breast tissues surrounding the tumor will be numbed using local anesthesia. To perform fine needle aspiration biopsies, tumor cells are withdrawn from the tumor using a very thin needle alone, or using a syringe.
These biopsies will be used to measure different genes and to predict how the cancer may respond to different treatments.
Based on the information from these gene measurements, a computer model will predict if the cancer is highly sensitive to chemotherapy and is likely to shrink to a great extent or disappear completely due to chemotherapy. This response prediction is done separately for estrogen receptor-positive and estrogen receptor-negative cancers.
Study Groups:
If the biopsies show that the cancer may respond well to standard T/FAC or T/FEC chemotherapy, you will receive the chemotherapy before surgery (Group 1).
If the biopsies show that the cancer may not respond as well to standard T/FAC or T/FEC chemotherapy, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups.
- If you are in Group 2, you will receive T/FAC or T/FEC chemotherapy before surgery. One (1) out of 3 participants whose cancer may not respond as well will be assigned to this group.
- If you are in Group 3, you will receive T/FAC or T/FEC chemotherapy combined with bevacizumab before surgery. Two (2) out of 3 participants whose cancer may not respond as well will be assigned to this group.
Your doctor will decide if you receive T/FAC or T/FEC.
Study Drug Administration:
Groups 1 and 2:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 3-4 hours. This chemotherapy treatment is considered routine standard of care and you may receive this treatment closer to home outside of M. D. Anderson.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Group 3:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 2 weeks during Weeks 1-18, you will receive bevacizumab by vein once over about 1-2 hours. If your doctor thinks is it necessary, and based on heart related test results, you may only receive bevacizumab during Weeks 1-12.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 4 hours. You must receive your chemotherapy at M. D. Anderson if you are in this group.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Study Visits:
All participants will have routine visits at M. D. Anderson at least once every 12 weeks during chemotherapy. Your doctor will determine the tests and procedures to be performed.
If you are assigned to Group 3, you will also have the following additional procedures.
- You will have a urine analysis within 1 month after starting therapy.
- You will have an echocardiogram to check your heart's health within 3 months after you begin treatment.
Length of Study:
You may receive chemotherapy for up to 6 months. Once surgery is performed, your participation in this study is complete. Your doctor will decide together with you what further treatment you will need after surgery.
This is an investigational study. The biopsy and testing to predict response to chemotherapy is not FDA approved or commercially available. Its use in this study is investigational. The chemotherapy and surgery are standard of care for patients with breast cancer. The addition of bevacizumab to treatment is also investigational.
Up to 303 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, Fluorouracil, Doxorubicin, Epirubicin, Cyclophosphamide
- Keywords
- Gene signatures, HER-2 normal stage I-III breast cancer, Estrogen Receptor, ER-positive, ER-negative, RCB categories II-III, Neoadjuvant Chemotherapy, adjuvant systemic therapy, molecular testing, Fluorouracil, 5-fluorouracil, 5-FU, Doxorubicin, Adriamycin, Rubex, Epirubicin, Ellence, Cyclophosphamide, Cytoxan, Neosar
- 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
Also called Taxol
80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
FluorouracilDrug
Also called 5-FU, Adrucil, Efudex
500 mg/m2 for 4 courses (once every 7 days)
DoxorubicinDrug
Also called Rubex, Adriamycin
50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
EpirubicinDrug
Also called Ellence
100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
CyclophosphamideDrug
Also called Cytoxan, Neosar
500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
BevacizumabDrug
Also called Avastin, Anti-VEGF monoclonal, rhuMAb-VEGF
10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ER-Positive | Experimental | Participants with Estrogen Receptor (ER)-Positive breast cancers receive Standard T/FAC or T/FEC chemotherapy before surgery.
T/FAC or T/FEC: Combination chemotherapy with sequential paclitaxel (80 mg/m2) weekly x 12 weeks followed by 5-fluorouracil (500 mg/m2), cyclophosphamide (500 mg/m2) and doxorubicin (50 mg/m2) or epirubicin (100 mg/m2) (FAC or FEC) once every 3 weeks for 4 treatments. Receives: Drug: Paclitaxel; Drug: Fluorouracil; Drug: Doxorubicin; Drug: Epirubicin; Drug: Cyclophosphamide |
| Group 2: ER-Negative | Experimental | Participants with ER-negative cancers (randomized between Group 2 \& Group 3), Standard T/FAC or T/FEC chemotherapy before surgery. Receives: Drug: Paclitaxel; Drug: Fluorouracil; Drug: Doxorubicin; Drug: Epirubicin; Drug: Cyclophosphamide |
| Group 3: ER-Negative + Bevacizumab | Experimental | Participants with ER-negative cancers (randomized between Group 2 \& Group 3), T/FEC chemotherapy combined with 10 mg Bevacizumab every 2 weeks during first 3 treatments before surgery. Receives: Drug: Paclitaxel; Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response Rate in Patients
Response is defined as pathologic complete (pCR/RCB-0) or near complete (RCB-I) response pathologic finding after completion of chemotherapy.
Measured: Every 3-4 weeks during chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startSep 2010
Why it stopped: Recent developments lead to re-evaluation of study.
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.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lajos Pusztai, MD, DPHIL, Study chair, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159236
- Sponsor's protocol ID
- 2008-0765
- Status last verified
- Jul 2012
- First submitted
- 7 Jul 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Triaging of Newly Diagnosed Breast Cancer for Preoperative Therapies
- ClinicalTrials.gov ID
- NCT01159236
- Acronym / sponsor ID
- 2008-0765
- Conditions
- Breast Cancer
- Keywords
- Gene signatures, HER-2 normal stage I-III breast cancer, Estrogen Receptor, ER-positive, ER-negative, RCB categories II-III, Neoadjuvant Chemotherapy, adjuvant systemic therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recent developments lead to re-evaluation of study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2010
- First posted
- 9 Jul 2010 (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 goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients. Gene signatures may be able to help researchers predict who will respond to chemotherapy given before surgery.
Detailed description
At this time, treatment of stage I-III breast cancer for patients who are at high risk for the cancer returning is surgery and chemotherapy. If the cancer is positive for estrogen hormone receptor, patients also have endocrine therapy.
The most common standard chemotherapy treatment regimens for breast cancer at M. D. Anderson are paclitaxel (T), followed by treatments with fluorouracil (F), doxorubicin (A) or epirubicin (E), and cyclophosphamide (C). These chemotherapy combinations are known as T/FAC and T/FEC. However, not all patients respond to these treatments, so researchers at M. D. Anderson have developed tests to predict how much a person's breast cancer might respond to T/FAC or T/FEC chemotherapy.
Fine needle aspiration (FNA) of the tumor are collected after numbing the skin of the breast with local anesthesia, and the genes within the FNA sample are measured to calculate the results of treatment prediction tests before treatment is selected.
In this research study, the gene-based tests will help to select treatment based on the predictions of response to chemotherapy, and to then measure the tumor response from the surgery after the treatment.
Study Drugs:
T/FAC and T/FEC are designed to damage the DNA (genetic material of cells), which may cause cancer cells to die.
Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells and make them more susceptible to chemotherapy.
Tumor Biopsies:
If you are found eligible to take part in this study, you will have 3-4 fine needle biopsies of the tumor collected. The skin over the tumor and the breast tissues surrounding the tumor will be numbed using local anesthesia. To perform fine needle aspiration biopsies, tumor cells are withdrawn from the tumor using a very thin needle alone, or using a syringe.
These biopsies will be used to measure different genes and to predict how the cancer may respond to different treatments.
Based on the information from these gene measurements, a computer model will predict if the cancer is highly sensitive to chemotherapy and is likely to shrink to a great extent or disappear completely due to chemotherapy. This response prediction is done separately for estrogen receptor-positive and estrogen receptor-negative cancers.
Study Groups:
If the biopsies show that the cancer may respond well to standard T/FAC or T/FEC chemotherapy, you will receive the chemotherapy before surgery (Group 1).
If the biopsies show that the cancer may not respond as well to standard T/FAC or T/FEC chemotherapy, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups.
- If you are in Group 2, you will receive T/FAC or T/FEC chemotherapy before surgery. One (1) out of 3 participants whose cancer may not respond as well will be assigned to this group.
- If you are in Group 3, you will receive T/FAC or T/FEC chemotherapy combined with bevacizumab before surgery. Two (2) out of 3 participants whose cancer may not respond as well will be assigned to this group.
Your doctor will decide if you receive T/FAC or T/FEC.
Study Drug Administration:
Groups 1 and 2:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 3-4 hours. This chemotherapy treatment is considered routine standard of care and you may receive this treatment closer to home outside of M. D. Anderson.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Group 3:
Once a week during Weeks 1-12, you will receive paclitaxel by vein over about 1-2 hours.
Once every 2 weeks during Weeks 1-18, you will receive bevacizumab by vein once over about 1-2 hours. If your doctor thinks is it necessary, and based on heart related test results, you may only receive bevacizumab during Weeks 1-12.
Once every 3 weeks during Weeks 13-24, you will receive T/FAC or T/FEC by vein over about 4 hours. You must receive your chemotherapy at M. D. Anderson if you are in this group.
After all chemotherapy, you will have surgery at M. D. Anderson to remove the cancer.
Study Visits:
All participants will have routine visits at M. D. Anderson at least once every 12 weeks during chemotherapy. Your doctor will determine the tests and procedures to be performed.
If you are assigned to Group 3, you will also have the following additional procedures.
- You will have a urine analysis within 1 month after starting therapy.
- You will have an echocardiogram to check your heart's health within 3 months after you begin treatment.
Length of Study:
You may receive chemotherapy for up to 6 months. Once surgery is performed, your participation in this study is complete. Your doctor will decide together with you what further treatment you will need after surgery.
This is an investigational study. The biopsy and testing to predict response to chemotherapy is not FDA approved or commercially available. Its use in this study is investigational. The chemotherapy and surgery are standard of care for patients with breast cancer. The addition of bevacizumab to treatment is also investigational.
Up to 303 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: ER-Positive | Experimental | Drug: Paclitaxel, Drug: Fluorouracil, Drug: Doxorubicin, Drug: Epirubicin, Drug: CyclophosphamideParticipants with Estrogen Receptor (ER)-Positive breast cancers receive Standard T/FAC or T/FEC chemotherapy before surgery. T/FAC or T/FEC: Combination chemotherapy with sequential paclitaxel (80 mg/m2) weekly x 12 weeks followed by 5-fluorouracil (500 mg/m2), cyclophosphamide (500 mg/m2) and doxorubicin (50 mg/m2) or epirubicin (100 mg/m2) (FAC or FEC) once every 3 weeks for 4 treatments. |
| Group 2: ER-Negative | Experimental | Drug: Paclitaxel, Drug: Fluorouracil, Drug: Doxorubicin, Drug: Epirubicin, Drug: CyclophosphamideParticipants with ER-negative cancers (randomized between Group 2 \& Group 3), Standard T/FAC or T/FEC chemotherapy before surgery. |
| Group 3: ER-Negative + Bevacizumab | Experimental | Drug: Paclitaxel, Drug: Fluorouracil, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: BevacizumabParticipants with ER-negative cancers (randomized between Group 2 \& Group 3), T/FEC chemotherapy combined with 10 mg Bevacizumab every 2 weeks during first 3 treatments before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients 18 years of age or older with histologically confirmed HER2-normal (defined as fluorescence in situ hybridization, FISH < 2.2 or immunohistochemistry, IHC <3+ if FISH result is not available) invasive carcinoma of the breast for whom systemic adjuvant therapy is clinically indicated.
- Patients must have intact cancer in the breast and intact regional lymph nodes (diagnostic core needle or fine needle biopsies are allowed).
- Routine estrogen, progesterone and HER-2 receptor determination must be performed before starting therapy.
- Patients with prior history of breast cancer are eligible.
- Patients with bilateral breast cancers are eligible.
Key exclusion criteria (11 listed)
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, including: uncompensated congestive heart failure, myocardial infarction within the past 12 months, pre-existing peripheral neuropathy > grade 2, prior doxorubicin therapy with > cumulative dose of 240 mg/m^2
- Women who had lumpectomy or surgical partial excisional biopsy of the cancer, or sentinel lymph node biopsy of a positive node, before starting preoperative therapy.
- Exclusion criteria for bevacizumab therapy; inadequately controlled hypertension (defined as systolic blood pressure >/= 140 mmHg and/or diastolic blood pressure >/= 90 mmHg).
- Exclusion criteria for bevacizumab therapy, prior history of hypertensive crisis or hypertensive encephalopathy, stroke or transient ischemic attacks.
- Exclusion criteria for bevacizumab therapy, history of myocardial infarction, unstable angina or congestive heart failure within 12 months prior to starting 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 |
|---|---|---|
| PaclitaxelAlso: Taxol80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses. | Drug | Group 1: ER-Positive, Group 2: ER-Negative, Group 3: ER-Negative + Bevacizumab |
| FluorouracilAlso: 5-FU, Adrucil, Efudex500 mg/m2 for 4 courses (once every 7 days) | Drug | Group 1: ER-Positive, Group 2: ER-Negative, Group 3: ER-Negative + Bevacizumab |
| DoxorubicinAlso: Rubex, Adriamycin50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments | Drug | Group 1: ER-Positive, Group 2: ER-Negative |
| EpirubicinAlso: Ellence100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2. | Drug | Group 1: ER-Positive, Group 2: ER-Negative, Group 3: ER-Negative + Bevacizumab |
| CyclophosphamideAlso: Cytoxan, Neosar500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments. | Drug | Group 1: ER-Positive, Group 2: ER-Negative, Group 3: ER-Negative + Bevacizumab |
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal, rhuMAb-VEGF10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC) | Drug | Group 3: ER-Negative + Bevacizumab |
Primary outcome
Pathological Response Rate in Patients
Time frame: Every 3-4 weeks during chemotherapy.
Response is defined as pathologic complete (pCR/RCB-0) or near complete (RCB-I) response pathologic finding after completion of chemotherapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Lajos Pusztai, MD, DPHIL study chair
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel, Fluorouracil and Doxorubicin in people with Breast Cancer, run by M.D. Anderson Cancer Center.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Pathological Response Rate in Patients (time frame: Every 3-4 weeks during chemotherapy.). 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 31 Jul 2012.