28 Participants Needed
University of Illinois at Chicago logo

Neoadjuvant Therapy for Breast Cancer

(BRE-10 Trial)

Recruiting in Chicago (>99 mi)
kh
MC
Overseen ByMercedes Carrasquillo, BS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Illinois at Chicago
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?

Adult men and women with early-stage, IHC/FISH-defined HER2-positive breast cancer will have a MammaPrint®/BluePrint® assay performed on the diagnostic biopsy specimen, ordered by the treating Oncologist as standard care

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that alter the metabolism or tolerability of the trial drugs, you may need to adjust them. It's best to discuss your specific medications with the trial team.

Is neoadjuvant therapy for breast cancer using docetaxel and paclitaxel generally safe?

Docetaxel and paclitaxel, used in breast cancer treatment, have been associated with side effects like hypersensitivity reactions and fluid retention. However, newer formulations like albumin-bound paclitaxel and nanosomal docetaxel lipid suspension have shown better tolerance and reduced toxicity in clinical studies.12345

How is the neoadjuvant therapy for breast cancer using Docetaxel, Nab-paclitaxel, Paclitaxel, Pertuzumab, and Trastuzumab different from other treatments?

This treatment is unique because it combines multiple drugs, including nanoparticle albumin-bound paclitaxel, which has shown greater efficacy and less toxicity compared to traditional docetaxel in some studies. The use of these specific drugs together may offer a novel approach to treating breast cancer, especially in cases where other treatments have been less effective.56789

What data supports the effectiveness of this drug for breast cancer?

Research shows that nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is more effective and has fewer side effects than docetaxel in treating metastatic breast cancer. It also has a higher response rate and longer survival time compared to conventional paclitaxel.156910

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage HER2-positive breast cancer, as confirmed by specific tests. They should be fit enough for chemotherapy and surgery to remove the breast tumor and examine nearby lymph nodes. There must be no signs of cancer spread elsewhere in the body.

Inclusion Criteria

My breast cancer was confirmed by a biopsy within the last 90 days.
My cancer is HER2-positive based on specific tests.
My cancer has not spread to distant parts of my body.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant chemotherapy with Taxane options and HER2-targeted therapy

16 weeks
Weekly visits for chemotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Regular visits for safety and quality of life assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Docetaxel
  • Nab-paclitaxel
  • Paclitaxel
  • Pertuzumab
  • Trastuzumab
Trial Overview The study is testing how well different chemotherapy drugs (Docetaxel, Trastuzumab, Pertuzumab, Paclitaxel, Nab-paclitaxel) work before surgery in patients whose tumors have a certain genetic profile indicating they are likely to respond to treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Single Treatment ArmExperimental Treatment5 Interventions

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

🇺🇸
Approved in United States as Taxotere for:
🇪🇺
Approved in European Union as Taxotere for:
🇨🇦
Approved in Canada as Taxotere for:
🇯🇵
Approved in Japan as Taxotere for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials
653
Recruited
1,574,000+

Published Research Related to This Trial

In a study involving 152 patients with HER2- early-stage breast cancer, weekly nab-paclitaxel showed comparable efficacy to docetaxel in achieving pathologic complete response (pCR) rates, with 12% for docetaxel and 17% for nab-paclitaxel, indicating it is a viable alternative for neoadjuvant chemotherapy.
Nab-paclitaxel was associated with a similar incidence of severe adverse events compared to docetaxel, but notably, it did not cause any grade 3/4 peripheral sensory neuropathy, suggesting a better safety profile for patients.
Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2- Early-stage Breast Cancer.Kuwayama, T., Nakamura, S., Hayashi, N., et al.[2022]
Nanoparticle albumin-bound paclitaxel (ABI-007, Abraxane) is a safer alternative to conventional paclitaxel for breast cancer treatment, as it eliminates the need for toxic solvents and premedication.
Recent trials indicate that ABI-007 is well tolerated and offers superior outcomes compared to standard paclitaxel, including higher response rates, longer time to tumor progression, and extended survival in patients with metastatic breast cancer.
Nanoparticle albumin-bound paclitaxel (ABI-007): a newer taxane alternative in breast cancer.Moreno-Aspitia, A., Perez, EA.[2023]
Albumin-bound paclitaxel has demonstrated significant clinical efficacy in treating metastatic breast cancer, as shown in phase II and III trials, making it a promising alternative to standard formulations.
This formulation is associated with better tolerance and safety compared to traditional solvent-based paclitaxel, suggesting it may reduce adverse effects for patients.
Albumin-bound paclitaxel: the benefit of this new formulation in the treatment of various cancers.Montana, M., Ducros, C., Verhaeghe, P., et al.[2018]

Citations

Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2- Early-stage Breast Cancer. [2022]
Nanoparticle albumin-bound paclitaxel (ABI-007): a newer taxane alternative in breast cancer. [2023]
Albumin-bound paclitaxel: the benefit of this new formulation in the treatment of various cancers. [2018]
Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. [2023]
Efficacy and Safety of Albumin-Bound Paclitaxel Compared to Docetaxel as Neoadjuvant Chemotherapy for HER2-Negative Breast Cancer. [2022]
Alternative drug formulations of docetaxel: a review. [2022]
Nanosomal Docetaxel Lipid Suspension-Based Chemotherapy in Breast Cancer: Results from a Multicenter Retrospective Study. [2023]
Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients. [2018]
Efficacy comparisons of solvent-based paclitaxel, liposomal paclitaxel, nanoparticle albumin-bound paclitaxel, and docetaxel after neoadjuvant systemic treatment in breast cancer. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Primary resistance to docetaxel-based chemotherapy in metastatic breast cancer patients correlates with a high frequency of BRCA1 mutations. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security