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A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2


Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned
to either group.

If you are in Group 1, you will receive paclitaxel for 4 cycles. You also will be treated
with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC
or FAC.

If you are in Group 2, you will receive eribulin for 4 cycles. You will also be treated
with FAC or FEC for 4 cycles. Your treating doctor will decide whether you will receive FEC
or FAC.

Each cycle is 21 days.

Study Drug Administration for Group 1:

You will receive paclitaxel by vein over 1 hour on Days 1, 8, and 15 of each 21-day study
cycle.

Before the infusion, you will be given drugs by vein, to help decrease the risk of an
allergic reaction.

If you have severe side effects, future treatments may be delayed, the dose may be
decreased, or you may be taken off study.

Once you have received 4 cycles of paclitaxel, you will receive either FEC or FAC
chemotherapy for 4 cycles. Your treating doctor will decide whether you will receive FEC or
FAC.

Study Drug Administration for Group 2:

You will receive eribulin by vein over 2-5 minutes on Days 1 and 8 of each 21-day study
cycle.

Once you have received 4 cycles of eribulin, you will receive FEC or FAC chemotherapy for 4
cycles. Your treating doctor will decide whether you will receive FEC or FAC.

FEC or FAC Treatment:

After you have received 4 cycles of either paclitaxel or eribulin, you will receive FEC or
FAC.

If you are given FEC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes,
epirubicin by vein over 30 minutes, and cyclophosphamide by vein over 30-60 minutes on Day 1
of every 21-day cycle.

If you are given FAC chemotherapy, you will receive 5-Fluorouracil by vein over 15 minutes,
doxorubicin by vein over 15 minutes, and cyclophosphamide by vein over 30-60 minutes on Day
1 of 21-day cycle.

Before FEC or FAC chemotherapy, you will be given drugs by vein to help decrease the risk of
allergic reaction. These drugs will include dexamethasone and zofran.

Study Visits During Paclitaxel or Eribulin:

On Day 1 of each cycle: If you have had these tests within 10 days before Day 1 of Cycle 1,
they may not need to be repeated.

- You will have a physical exam, including a measurement of your weight and vital signs.

- You will be asked about any side effects you may be having and any drugs you may be
taking.

- Your performance status will be recorded.

- Blood (about 1-2 teaspoons) will be drawn for routine tests.

On Days 8 and 15 of Cycle 1-4, blood (about 1 teaspoon) will be drawn for routine tests.

At Week 12, you will have a core biopsy.

At the end of Cycle 4:

- You will have an ultrasound of the breast to check the status of the disease.

- You will have an ECHO or MUGA scan.

- You will have a core biopsy and fine needle aspiration of the tumor. A small needle
will be inserted into the tumor at the safest and easiest location to withdraw cancer
cells. This will be used to learn which tumor markers may predict who may best respond
to therapy.

Study Visits During FEC or FAC Chemotherapy:

On Day 1 of every third week:

- You will have a physical exam, including a measurement of your weight and vital signs.

- You will be asked about any side effects you may be having and any drugs you may be
taking.

- Your performance status will be recorded.

- Blood (about 1-2 teaspoons) will be drawn for routine tests.

After you have finished FEC or FAC treatment, you may have surgery. At the end of the
chemotherapy treatment, you will be referred to the breast surgeon to discuss surgery. There
is an small possibility (less than 3%) that tumor has gotten worse during treatment, and
additional chemotherapy may be necessary.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Paclitaxel, doxorubicin, epirubicin, and cyclophosphamide
are FDA approved and commercially available for the treatment of breast cancer. Eribulin is
FDA approved and commercially available to treat metastatic breast cancer in patients who
have received at least 2 chemotherapy regimens for the treatment of metastatic disease. The
use of eribulin with the FEC/FAC regimens is investigational for neoadjuvant treatment.

Up to 152 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:



1. Signed written informed consent

2. Histologically confirmed primary invasive adenocarcinoma of the breast.

3. Clinical stage breast cancer T2-3, N0-3, M0

4. Negative HER-2/neu expression as determined by local hospital laboratory using
Fluorescence In Situ Hybridization (FISH), or is less or equal to 1+ using
Immunohistochemistry (IHC).

5. No prior treatment for primary invasive adenocarcinoma of the breast such as
irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy
or surgery. Subjects receiving hormone replacement treatment (HRT) are eligible if
this therapy is discontinued at least 2 weeks before starting study therapy.
Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.

6. Karnofsky performance status (KPS) of 80 - 100

7. Accessible for treatment and follow-up.

8. Baseline MUGA or echocardiogram scans with LVEF of > 50%.

9. Normal PTT and either INR or PT < 1.5 x ULN.

10. Men or women 18 years of age or older.

11. Women of childbearing potential (WOCBP) WOCBP must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 8 weeks after the
last dose of investigational product in such a manner that the risk of pregnancy is
minimized.

12. Willingness to have core biopsies and/or FNA before treatment and at the end of 12
weeks of the treatment.

Exclusion Criteria:

1. Women who are pregnant (including positive pregnancy test at enrollment or prior to
study drug administration) or breast-feeding.

2. Disease free of prior malignancy for < 5 years with the exception of curatively
treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma
in situ of the cervix.

3. Absolute neutrophils count (ANC) < 1500/mm^3

4. Total bilirubin > 1.5 times the upper limit of normal (ULN)

5. AST or ALT > 2.5 times the upper limit of normal (ULN)

6. Platelets < 100,000/mm^3.

7. Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or
calculated by Cockcroft-Galt method)

8. Evidence of metastatic breast cancer following a standard tumor staging work-up

9. Evidence of inflammatory breast cancer.

10. Evidence of any grade 2 sensory or motor neuropathy.

11. Known human immunodeficiency viral (HIV) infection

12. Serious intercurrent infections or non-malignant medical illness that are
uncontrolled or the control of which may be jeopardized by this therapy.

13. Psychiatric disorders or other conditions rendering the subject incapable of
complying with the requirements of the protocols.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response (pCR)

Outcome Description:

Pathologic complete response (pCR) defined as complete absence of any viable invasive cancer cells in the resected breast and lymph nodes. Participants undergo definitive breast surgery 4 -6 weeks from last dose of FAC/FEC-regimen. Tumors removed by either lumpectomy with axillary dissection (i.e. breast conservation surgery) or modified radical mastectomy (i.e. mastectomy with axillary clearance). Surgical specimens (breast and axillary lymph node tissue) evaluated for pathological complete response.

Outcome Time Frame:

4 -6 weeks from last dose of FAC/FEC-regimen.

Safety Issue:

Yes

Principal Investigator

Ricardo H Alvarez, MD,M.Sc.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2012-0167

NCT ID:

NCT01593020

Start Date:

August 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Early Stage Breast Cancer Not Overexpressing HER-2
  • Primary invasive adenocarcinoma of the breast
  • Paclitaxel
  • Taxol
  • Eribulin
  • E7389
  • 5-Fluorouracil
  • 5-FU
  • Adrucil
  • Efudex
  • Epirubicin
  • Ellence
  • Cyclophosphamide
  • Cytoxan
  • Neosar
  • Doxorubicin
  • Doxorubicin hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex
  • Breast Neoplasms

Name

Location
UT MD Andreson Cancer Center Houston, Texas  77030