Eribulin + AC Chemotherapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Filipa Lynce, MD - Dana-Farber Cancer ...

Overseen ByFilipa Lynce, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

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.

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.

My breast cancer diagnosis was confirmed through a biopsy.

I am 18 years old or older.

My cancer has not spread to my organs or bones, but may be in many lymph nodes.

My cancer is not HER2 positive according to specific guidelines.

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I am HIV-positive and on combination antiretroviral therapy.

I have not been treated with eribulin, paclitaxel, doxorubicin, or cyclophosphamide.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Arm B: AC > EribulinExperimental Treatment3 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 > ACExperimental Treatment3 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