Eribulin + AC Chemotherapy for Breast Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Antiretrovirals, Eribulin, Paclitaxel, others

Disqualifiers: Pregnancy, HIV, Cardiac illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

22 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on investigational agents or HIV antiretroviral therapy, you would not be eligible to participate.

What data supports the effectiveness of the drug Eribulin in treating breast cancer?

Eribulin has been shown to increase overall survival in patients with advanced breast cancer who have already tried at least two other chemotherapy treatments. In a study, patients taking Eribulin lived longer on average (13.2 months) compared to those who did not (10.6 months). ^{1 2 3 4 5}

Is the combination of Eribulin and AC chemotherapy safe for humans?

The combination of drugs similar to Eribulin and AC chemotherapy has been studied, showing that while effective, they can cause side effects like nausea, vomiting, and heart issues. However, some studies suggest that certain drugs in this combination may have fewer side effects compared to others, indicating a potentially safer profile. ^{6 7 8 9 10}

What makes the Eribulin + AC chemotherapy drug unique for breast cancer treatment?

The Eribulin + AC chemotherapy combines eribulin, a non-taxane microtubule inhibitor, with Adriamycin and Cyclophosphamide, offering a novel approach for patients with advanced breast cancer who have previously been treated with anthracyclines and taxanes. Eribulin is known for its unique action of reversing epithelial-mesenchymal transition and remodeling tumor blood vessels, which may provide benefits in certain breast cancer cases. ^{1 2 3 11 12}

What is the purpose of this trial?

This research study is studying a drug called eribulin combined with standard treatment as a possible preoperative treatment for HER2 negative inflammatory breast cancer.

Research Team

Filipa Lynce, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with HER2-negative inflammatory breast cancer, no prior therapy for one affected breast, and no metastatic cancer in organs or bones. Participants need normal heart function and organ/marrow health, must not be pregnant or breastfeeding, agree to use contraception, and have no severe illnesses that could affect study participation.

Inclusion Criteria

I am mostly able to carry out my daily activities.

My blood tests show my organs are functioning well.

I have been diagnosed with inflammatory breast cancer.

Exclusion Criteria

You have had allergic reactions to drugs similar to eribulin or other drugs being used in the study.

Your heart's electrical activity (QT interval) is longer than normal.

I am HIV-positive and on combination antiretroviral therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Therapy

Participants receive preoperative chemotherapy with either Eribulin followed by AC or AC followed by Eribulin

20 weeks

8 cycles of treatment

Surgery

Surgical removal of the breasts (Mastectomy) and axillary lymph node dissection

Radiation Therapy

Participants receive radiation therapy post-surgery

Follow-up

Participants are monitored for disease-free survival and overall survival

5 years

Every 3 months for 1 year, then every 6 months for 4 years, then annually

Treatment Details

Interventions

• Adriamycin
• Cyclophosphamide
• Eribulin

Trial Overview The study tests eribulin combined with standard chemotherapy drugs Adriamycin (doxorubicin) and Cyclophosphamide as a preoperative treatment. It aims to evaluate the effectiveness of this drug combination in treating patients before they undergo surgery for their breast cancer.

Participant Groups

Group I: Arm B: AC > Eribulin Experimental Treatment 3 Interventions

* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle * Two research breast biopsies * Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Group II: Arm A: Eribulin > AC Experimental Treatment 3 Interventions

* Eribulin-Administered via iv, at predetermined dosage and schedule per cycle * Two research breast biopsies * Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle * Cyclophosphamide (AC) via iv a predetermined dosage and schedule per cycle * Surgical Removal of the breasts (Mastectomy) and axillary lymph node dissection * Radiation Therapy * Endocrine Therapy (if applicable) * Optional 5 Patient-Optional DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging) scans

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

Eribulin mesylate is an FDA-approved treatment for patients with metastatic breast cancer who have already undergone at least two chemotherapy regimens, including an anthracycline and a taxane.

This drug is specifically designed for patients whose cancer has not responded to previous treatments, providing a new option for those with anthracycline- and taxane-refractory metastatic breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eribulin mesylate (Halaven) for breast cancer. [2016]

The combination of eribulin and cyclophosphamide showed a clinical benefit rate of 79.5% in 44 patients with advanced breast cancer, indicating it is an effective treatment option for heavily pretreated individuals.

While the treatment was generally well-tolerated, neutropenia was the most common severe side effect, affecting 47.7% of patients, highlighting the need for monitoring blood cell counts during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase Ib/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer. Gumusay, O., Huppert, LA., Magbanua, MJM., et al.[2023]

Eribulin, a microtubule dynamics inhibitor, has been approved for treating locally advanced or metastatic breast cancer in patients who have already undergone at least two chemotherapy regimens, showing a median overall survival increase from 10.6 months to 13.2 months compared to control.

The recommended dosing regimen for eribulin is 1.23 mg/m² administered intravenously on days 1 and 8 of a 3-week cycle, with common side effects including fatigue and neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. Pean, E., Klaar, S., Berglund, EG., et al.[2016]

In a phase II clinical trial involving 55 patients with operable breast cancer, preoperative chemotherapy using nanoparticle albumin-bound paclitaxel (nab-PTX) followed by an epirubicin and cyclophosphamide regimen achieved a pathological complete response (pCR) rate of 22.2%, indicating its efficacy in treating this condition.

The study found that HER2-positive patients had a significantly higher pCR rate of 60%, suggesting that HER2 status is an important factor in predicting treatment response, while the overall safety profile of the treatment was considered tolerable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer: a multicenter phase II trial. Futamura, M., Nagao, Y., Ishihara, K., et al.[2018]

Epirubicin, when used in combination with cyclophosphamide and 5-fluorouracil for adjuvant chemotherapy in 10 patients with Stage 2 breast cancer, showed a manageable toxicity profile, primarily causing moderate granulocytopenia without any cases of granulocytopenic fever.

While some patients experienced significant side effects like vomiting and hair loss, the absence of severe cardiac issues suggests that epirubicin may be less cardiotoxic than doxorubicin, indicating its potential for further evaluation in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trial of adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) for stage II breast cancer. Jones, SE., Mennel, RG., Peters, GN., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of Sequential Eribulin Versus Paclitaxel Followed by FAC/FEC as Neoadjuvant Therapy in Patients with Operable HER2-Negative Breast Cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Eribulin mesylate (Halaven) for breast cancer. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A phase Ib/II study of eribulin in combination with cyclophosphamide in patients with advanced breast cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The European medicines agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the committee for medicinal products for human use. [2016]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Eribulin (Halaven): a new, effective treatment for women with heavily pretreated metastatic breast cancer. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy for early breast cancer: optimal use of epirubicin. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[Epirubicin--results in breast cancer]. [2018]

8. Japan pubmed.ncbi.nlm.nih.gov

Preoperative neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer: a multicenter phase II trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Phase I trial of adjuvant chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) for stage II breast cancer. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy (PRADA II) trial: a randomized, placebo-controlled, multicenter trial. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Study of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Operable HER2-negative Breast Cancer. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. [2023]