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Alkylating agents
Arm 1: Anthracycline-based chemotherapy for Breast Cancer
Phase 3
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Awards & highlights
Study Summary
This trial is testing different chemotherapy combinations to see which is most effective in treating women with non-metastatic breast cancer.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive disease-free survival (IDFS)
Secondary outcome measures
Disease-free survival (DFS-DCIS)
Molecular predictors of efficacy
Overall survival (OS)
+2 moreTrial Design
2Treatment groups
Active Control
Group I: Arm 1: Anthracycline-based chemotherapyActive Control4 Interventions
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Group II: Arm 2: docetaxel + cyclophosphamideActive Control2 Interventions
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
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Who is running the clinical trial?
NSABP Foundation IncLead Sponsor
88 Previous Clinical Trials
138,431 Total Patients Enrolled
45 Trials studying Breast Cancer
100,459 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,929,571 Total Patients Enrolled
941 Trials studying Breast Cancer
1,542,095 Patients Enrolled for Breast Cancer
Norman Wolmark, MDPrincipal InvestigatorNSABP Foundation Inc
59 Previous Clinical Trials
81,846 Total Patients Enrolled
29 Trials studying Breast Cancer
66,994 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You should be in good physical condition with a performance status of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.You have breast cancer that is invasive and only on one side of your body.The lymph nodes on the same side as the cancer must not have advanced cancer cells beyond a certain stage.You must have had either your entire breast removed or a surgery to remove only the tumor (lumpectomy).If you had a mastectomy, the surgery must have removed all the cancerous cells from your breast tissue.If the initial lymph node biopsy shows no signs of cancer or very early stage of cancer, you may not need further lymph node removal.You have been treated with anthracyclines or taxanes for any type of cancer in the past.You have a heart condition that makes it unsafe to take the drugs used in the study.You have a lung disease that makes it difficult for you to breathe.You have had a major organ transplant or need to take medicine to suppress your immune system over a long period of time.You have a medical condition that prevents you from taking corticosteroids.You have a medical condition that would stop you from receiving the study treatment or make it difficult for you to attend necessary follow-up appointments.You cannot have taken any experimental medication within the 30 days leading up to the study.The size of your tumor must be between small and medium as determined by a pathology evaluation.Your breast cancer must test negative for a specific protein called Human Epidermal Growth Factor Receptor 2 (HER2), based on current guidelines. If there is uncertainty in the test results, you can still participate if you are not planning to receive HER2-targeted therapy.If you have a lumpectomy, the removed tissue must be free of cancer cells or pre-cancerous cells called DCIS as determined by the local pathologist. If cancer cells are found at the edge of the removed tissue, you will need further surgery to remove any remaining cancer cells. If further surgery doesn't remove all the cancer cells, you'll need a total mastectomy to be eligible for the trial. However, if the margin is positive for LCIS, you are still eligible without needing further surgery.Your tumor is either larger than 2 cm, or between 1-2 cm with high-grade histology or a high Oncotype DX® Recurrence Score. If your tumor is between 1-2 cm and ER positive, your PgR status doesn't matter.You are currently taking any hormone therapy related to your gender.You had cancer in a part of your body other than the breast within the last 5 years, unless it was a type of cancer that is allowed for this study.You are currently taking medication for hormone therapy like raloxifene, tamoxifen, or aromatase inhibitors.You have a mental health or addiction condition that could make it difficult for you to follow the study requirements.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Anthracycline-based chemotherapy
- Group 2: Arm 2: docetaxel + cyclophosphamide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Arm 1: Anthracycline-based chemotherapy been cleared by the FDA?
"Arm 1: Anthracycline-based chemotherapy has been studied enough that there is data to support its efficacy. Furthermore, because this is a Phase 3 trial, there is extensive safety data. Consequently, our team rates the safety of this intervention as a 3."
Answered by AI
What purpose does Arm 1: Anthracycline-based chemotherapy serve?
"kaposi's sarcoma aids related is often treated with Arm 1: Anthracycline-based chemotherapy. However, this treatment is not exclusive to kaposi's sarcoma aids related and can also be used to target leukemia, locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
Is this a brand-new clinical trial?
"As of right now, there are 2,015 active studies being conducted for Arm 1: Anthracycline-based chemotherapy in 3,849 different cities and 82 countries. The first trial of its kind started back in 1997 and was completed in Phase 3 drug approval. Alfacell Corporation sponsored the study and it involved 300 participants. In the 23 years since the initial study, 2,949 have been completed."
Answered by AI
Is Arm 1: Anthracycline-based chemotherapy a new treatment option?
"One potential study treatment, anthracycline-based chemotherapy, was first investigated in 1997 at Spectrum Health Hospital - Butterworth Campus. There have been 3049 completed trials and 2015 active trials as of this year. Pueblo, Colorado has a high concentration of these active studies."
Answered by AI
Are people with the specified medical condition able to join the clinical trial at this time?
"According to the listing on clinicaltrials.gov, this study is not currently looking for new patients to enroll. The study was first announced on April 1st, 2012 and received its last update on April 13th, 2022. Although this particular trial is not looking for new participants, there are 4706 other clinical trials that are."
Answered by AI
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