454 Participants Needed

Chemotherapy for Breast Cancer

Recruiting at 495 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on warfarin, you must have a stable dose with an INR of 3 or less and no active bleeding.

Is chemotherapy for breast cancer generally safe for humans?

Chemotherapy treatments like doxorubicin and paclitaxel have been studied for safety, with some reports of cardiac (heart-related) side effects, especially when used together. However, limiting the dose of doxorubicin can help manage these risks, and ongoing studies are exploring ways to reduce cardiac toxicity further. Other side effects of paclitaxel include allergic reactions, low white blood cell counts, nerve damage, and hair loss.12345

How is the chemotherapy drug combination of Cyclophosphamide, Doxorubicin Hydrochloride, and Paclitaxel unique for breast cancer treatment?

This chemotherapy drug combination is unique because it uses both anthracyclines (like Doxorubicin) and taxanes (like Paclitaxel) in a sequential regimen, which is a common and effective approach for reducing cancer recurrence in breast cancer patients. The combination is well-established for its safety and efficacy, providing a balance between effectiveness and manageable side effects.678910

What evidence supports the effectiveness of the drug combination used in the chemotherapy for breast cancer trial?

Research shows that combining paclitaxel and doxorubicin is highly effective in treating advanced breast cancer, with manageable side effects. Additionally, Abraxane and cyclophosphamide have shown better outcomes in recurrent breast cancer compared to other therapies, suggesting the potential effectiveness of this drug combination.1112131415

Who Is on the Research Team?

WM

William M Sikov

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Patient agrees to undergo pretreatment research biopsies
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.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive paclitaxel weekly for 12 weeks, followed by dose-dense doxorubicin and cyclophosphamide every 2 weeks for 4 cycles

19 weeks
Weekly visits for paclitaxel, bi-weekly visits for ddAC

Surgery

Definitive surgery, either modified radical mastectomy or breast-conserving surgery, is performed 4-8 weeks after completion of neoadjuvant therapy

4-8 weeks

Follow-up

Participants are monitored for safety, effectiveness, and recurrence-free survival

up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Carboplatin
  • Cyclophosphamide
  • Doxorubicin Hydrochloride
  • Paclitaxel
Trial Overview 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.
How Is the Trial Designed?
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.

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Cytoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇪🇺
Approved in European Union as Endoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇨🇦
Approved in Canada as Neosar for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇯🇵
Approved in Japan as Endoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Paclitaxel has shown high effectiveness in treating advanced breast cancer, including cases resistant to anthracyclines, prompting research into its combination with anthracyclines like doxorubicin.
Clinical trials of the paclitaxel/doxorubicin combination have reported promising response rates, although the toxicity profiles vary significantly based on the administration schedule used.
Paclitaxel and doxorubicin in metastatic breast cancer.Gehl, J., Boesgaard, M., Paaske, T., et al.[2015]
A randomized trial by the Eastern Cooperative Oncology Group (ECOG) is comparing the effectiveness of single-agent doxorubicin, single-agent paclitaxel, and their combination in treating metastatic breast cancer, with initial results currently being analyzed.
ECOG is also exploring ways to reduce the cardiac toxicity associated with doxorubicin by adding dexrazoxane, while ongoing trials are investigating the combination of carboplatin and paclitaxel to enhance treatment efficacy.
Paclitaxel doublets in metastatic breast cancer: Eastern Cooperative Oncology Group and Hoosier Oncology Group Studies.Sledge, GW.[2015]
In a study involving 2,305 women with primary breast cancer, intensifying the dose of cyclophosphamide in combination with doxorubicin did not lead to significant improvements in disease-free survival (DFS) or overall survival after 5 years.
Increasing the total dose of cyclophosphamide resulted in higher grade 4 toxicity, indicating that such intensification may not be safe or beneficial for patients outside of clinical trials.
Increased intensification and total dose of cyclophosphamide in a doxorubicin-cyclophosphamide regimen for the treatment of primary breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-22.Fisher, B., Anderson, S., Wickerham, DL., et al.[2017]

Citations

The efficacy and safety of preoperative chemotherapy with triweekly abraxane and cyclophosphamide followed by 5-Fluorouracil, epirubicin, and cyclophosphamide therapy for resectable breast cancer: a multicenter clinical trial. [2015]
Paclitaxel and doxorubicin in metastatic breast cancer. [2015]
Paclitaxel doublets in metastatic breast cancer: Eastern Cooperative Oncology Group and Hoosier Oncology Group Studies. [2015]
Increased intensification and total dose of cyclophosphamide in a doxorubicin-cyclophosphamide regimen for the treatment of primary breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-22. [2017]
Experience at the Istituto Nazionale Tumori with paclitaxel in combination with doxorubicin in women with untreated breast cancer. [2015]
Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study. [2023]
Combination chemotherapy with paclitaxel and doxorubicin for metastatic breast cancer. [2015]
Paclitaxel (Taxol)--a guide to administration. [2019]
Prospective assessment of cardiac toxicity during a randomized phase II trial of doxorubicin and paclitaxel in metastatic breast cancer. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
A network meta-analysis for toxicity of eight chemotherapy regimens in the treatment of metastatic/advanced breast cancer. [2018]
Cognitive impairment and elevated peripheral cytokines in breast cancer patients receiving chemotherapy. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Single Institution trial of anthracycline- and taxane-based chemotherapy for operable breast cancer: The ASTER study. [2019]
Sequencing of anthracyclines and taxanes in neoadjuvant and adjuvant therapy for early breast cancer. [2022]
A Phase II Study of Concurrent Docetaxel, Epirubicin and Cyclophosphamide as a Neoadjuvant Chemotherapy Regimen in Patients with Locally Advanced Breast Cancer. [2021]
15.United Statespubmed.ncbi.nlm.nih.gov
Docetaxel, doxorubicin and cyclophosphamide (the TAC regimen): an effective adjuvant treatment for operable breast cancer. [2016]
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