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Alkylating agents
Chemotherapy for Breast Cancer
Phase 2
Waitlist Available
Led By William M Sikov
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower gastrointestinal [GI] bleeding) within 6 months of registration are not eligible
Pregnant or nursing women are not eligible; all women of reproductive potential must have a negative pregnancy test at baseline and agree to use an effective, non-hormonal method of contraception during the entire period of treatment on the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial is testing paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide to see if it is effective in treating patients with breast cancer.
Who is the study for?
This trial is for patients with breast cancer that can be surgically removed. They must have hormone receptor-poor tumors, no significant bleeding or heart issues in the past 6 months, and normal organ function tests. Pregnant women are excluded, as are those who've had prior treatments for this cancer. Participants need to agree to biopsies and use non-hormonal contraception if applicable.Check my eligibility
What is being tested?
The study is testing how well paclitaxel works alone or combined with carboplatin and/or bevacizumab before surgery, followed by doxorubicin and cyclophosphamide. It aims to see if adding these drugs makes the tumor smaller compared to standard chemotherapy alone.See study design
What are the potential side effects?
Possible side effects include allergic reactions, bleeding risks from bevacizumab; nerve damage from paclitaxel; heart problems from doxorubicin; immune system suppression leading to infections from cyclophosphamide; fatigue and nausea are common with chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had serious bleeding episodes in the last 6 months.
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I am not pregnant or nursing and agree to use non-hormonal birth control during the study.
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My heart's pumping ability is within the normal range.
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My breast cancer was confirmed by a needle or small cut biopsy.
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My tumor is mostly negative for hormone receptors.
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My kidney function test shows less than 1g of protein in 24 hours.
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I can carry out all my usual activities without help.
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I don't have any serious wounds, ulcers, fractures, or recent major surgeries.
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I haven't had chemotherapy, hormone therapy, or radiation for this cancer.
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I do not have severe nerve pain or numbness.
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My invasive tumor is HER2-negative.
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I have not had heart failure, a heart attack, stroke, uncontrolled high blood pressure, or severe artery disease in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast
Secondary outcome measures
Clinical Response Assessed by Tumor Measurement
Count of Participants With a First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause
Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.
+5 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)Experimental Treatment6 Interventions
Patients receive paclitaxel and ddAC as in Arm I, bevacizumab as in Arm II, and carboplatin as in Arm III.
Group II: Arm III (paclitaxel, ddAC, carboplatin)Experimental Treatment5 Interventions
Patients receive paclitaxel and ddAC as in Arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
Group III: Arm II (paclitaxel, ddAC, bevacizumab)Experimental Treatment5 Interventions
Patients receive paclitaxel and ddAC as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
Group IV: Arm I (paclitaxel, doxorubicin, cyclophosphamide)Active Control4 Interventions
Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,699 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
William M SikovPrincipal InvestigatorAlliance for Clinical Trials in Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast tumor is at least 1 cm big, or I have measurable axillary adenopathy.Your kidney function is too high, with a filtration rate of more than 30 milliliters per minute.My breast cancer was confirmed by a needle or small cut biopsy.I have stage II-III breast cancer and plan to have surgery after initial treatment, but I don't have inflammatory breast cancer.I haven't had serious bleeding episodes in the last 6 months.I am not pregnant or nursing and agree to use non-hormonal birth control during the study.My heart's pumping ability is within the normal range.My tumor is mostly negative for hormone receptors.You have a platelet count of more than 100,000 per microliter.My kidney function test shows less than 1g of protein in 24 hours.Your ALT blood test results are not more than 2.5 times the normal range.Your total bilirubin level is no more than 1.5 times the upper limit of normal.My cancer is in more than one location but meets the study's requirements.I can carry out all my usual activities without help.I don't have any serious wounds, ulcers, fractures, or recent major surgeries.You have more than 1,000 granulocytes in a microliter of blood.I haven't had chemotherapy, hormone therapy, or radiation for this cancer.My blood clotting time is within safe limits, or if on warfarin, my INR is stable and <=3 without bleeding risks.I do not have severe nerve pain or numbness.My invasive tumor is HER2-negative.The amount of protein in your urine is not too high.I have not had heart failure, a heart attack, stroke, uncontrolled high blood pressure, or severe artery disease in the last year.Women who could become pregnant have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, doxorubicin, cyclophosphamide)
- Group 2: Arm II (paclitaxel, ddAC, bevacizumab)
- Group 3: Arm III (paclitaxel, ddAC, carboplatin)
- Group 4: Arm IV (paclitaxel, ddAC, bevacizumab, carboplatin)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any prior experiments that have studied Paclitaxel's effects?
"In 1997, the first clinical trial of Paclitaxel was conducted at Spectrum Health Hospital - Butterworth Campus. Since then, there have been 4015 completed trials and 2239 active ones; many of which are set in Saint Louis, Missouri."
Answered by AI
Has there been any precedent for this research?
"At present, there are 2239 ongoing Paclitaxel experiments across 87 nations and 3990 cities. The first trial for this drug was executed in 1997 by Alfacell with 300 patients taking part and concluding at Phase 3 of the drug approval process. Subsequent to that inaugural experiment, 4015 further trials have been completed successfully."
Answered by AI
To what extent might Paclitaxel be hazardous to patients?
"Paclitaxel has been evaluated for safety, resulting in a rating of 2 on our scale. This is because this drug's efficacy has not yet been proven and there are only limited data regarding its safety."
Answered by AI
How many subjects are currently participating in this experimental protocol?
"At present, this trial is not recruiting patients. Although the first posting for the study was on May 15th 2009 and it was last updated August 30 2022, no participants are needed currently. For those looking to join a medical study related to breast cancer or Paclitaxel in particular, there are 4,567 and 2,239 studies actively searching for volunteers respectively."
Answered by AI
Is there a broad range of sites facilitating this research across North America?
"This clinical trial is currently recruiting individuals from a total of 100 sites, including Saint Louis, Honolulu and Minneapolis. To reduce travel expenses associated with the enrolment process, it is important to select the closest location available."
Answered by AI
What afflictions is Paclitaxel typically deployed to manage?
"Paclitaxel is widely used to treat lymphoma, non-Hodgkin's sarcoma linked to AIDS, and recurrent cervical cancer."
Answered by AI
Is enrollment currently active for this clinical trial?
"This research programme is no longer accepting patients. The trial was first published on May 15th 2009 and last updated on August 30th 2022. Presently, there are 4567 clinical trials recruiting breast cancer candidates and 2239 Paclitaxel studies in search of participants."
Answered by AI
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