Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Inflammatory Breast Neoplasms

Breast Diseases

Skin Diseases

Inflammatory Breast Cancer

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Mitogens

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

* 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

* 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

Eribulin

administered IV with cyclophosphamide for 4 cycles

Adriamycin

administered IV with adriamycin for 4 cycles

Filipa Lynce, MD

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

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

Eribulin works by interfering with cancer cell division, growth, and spread.

The goal of this research study is to evaluate inflammatory breast cancer's response to treatment with eribulin followed by AC chemotherapy (Cohort A) and also the response to treatment with AC followed by Eribulin (Cohort B) when given as a preoperative chemotherapy treatment for participants with HER2 negative inflammatory breast cancer.

A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR.

Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence.

Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression.

Overall Survival (OS) will be defined two ways: among patients who undergo surgery, as time from surgery until death from any cause; and among all patients, as the time from treatment initiation until death from any cause. Censoring will use the date last known alive.

Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists.

This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category "Unknown" if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy.

Eisai Inc.

Dana-Farber Cancer Institute

Principal Investigator

Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. Remaining AEs are classified as Other AEs (OAE). Maximum grade toxicity by type was calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

* 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 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

Eribulin: administered IV for 4 cycles

Adriamycin: administered IV with cyclophosphamide for 4 cycles

Cyclophosphamide: administered IV with adriamycin for 4 cycles

Arm A: Eribulin Followed by AC

* Adriamycin (doxorubicin) via iv a predetermined dosage and schedule per cycle
* Cyclophosphamide 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

Eribulin: administered IV for 4 cycles

Adriamycin: administered IV with cyclophosphamide for 4 cycles

Cyclophosphamide: administered IV with adriamycin for 4 cycles

Arm B: AC Followed by Eribulin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

\<1% means negative, 1-10% means low positive, \>10% means positive

Estrogen Receptor Status

Stage IIIB: The tumor has spread to the chest wall or caused swelling or ulceration of the breast, or it is diagnosed as inflammatory breast cancer.

Stage IIIC: A tumor of any size that has spread to 10 or more axillary lymph nodes, the internal mammary lymph nodes, and/or the lymph nodes under the collarbone.

Stage IV (metastatic): The tumor can be any size and has spread to other organs, such as the bones, lungs, brain, liver, distant lymph nodes, or chest wall

Breast Cancer Stage

Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.10, Alternative hypothesis that proportion pCR ≥ 0.30. Hypothesized False Positive Rate(α)=10%; Hypothesized False Negative Rate(1-β)=10%.

Null Hypothesis: the proportion of participants experiencing pCR is ≤ 0.02, Alternative hypothesis that proportion pCR ≥ 0.23. Hypothesized False Positive Rate(α)=5%; Hypothesized False Negative Rate(1-β)=10%.

Spots Global Cancer Trial Database for A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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