Breast CancerPhase 2NCT01593020
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
A Phase 2 study testing Paclitaxel, Eribulin and 5-Fluorouracil in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Paclitaxel, Eribulin and 5-Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2012to 4 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Histologically confirmed primary invasive adenocarcinoma of the breast.
- Clinical stage breast cancer T2-3, N0-3, M0
- 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).
- 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 treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.
- Karnofsky performance status (KPS) of 80 - 100
Show all 12Show fewer
- The ability and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Baseline MUGA or echocardiogram scans with LVEF of > 50%.
- Normal PTT and either INR or PT < 1.5 x ULN.
- Men or women 18 years of age or older.
- Women of childbearing potential (WOCBP) must agree to use a medically acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drugs.
- Willingness to have core biopsies and/or FNA performed before the start of study treatment and at the end of 12 week on treatment.
Who cannot join
- Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
- Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.
- Absolute neutrophils count (ANC) < 1500/mm^3
- Total bilirubin > 1.5 times the upper limit of normal (ULN)
- AST or ALT > 2.5 times the upper limit of normal (ULN)
- Platelets < 100,000/mm^3.
Show all 13Show fewer
- Serum creatinine > 1.5 x ULN or creatinine clearance < 60 mL/min (measured or calculated by Cockcroft-Galt method)
- Evidence of metastatic breast cancer following a standard tumor staging work-up
- Evidence of inflammatory breast cancer.
- Evidence of any grade 2 sensory or motor neuropathy.
- Known human immunodeficiency viral (HIV) infection
- Serious intercurrent infections or non-malignant medical illness that are uncontrolled or the control of which may be jeopardized by this therapy.
- Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).
Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.
Read more
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.
Read the detailed description
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.
Eribulin will be provided at no cost to you while you are on this study. You and/or your insurance provider will be responsible for the cost of paclitaxel, doxorubicin, epirubicin, and cyclophosphamide.
Up to 162 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Paclitaxel, Eribulin, 5-Fluorouracil, Epirubicin, Cyclophosphamide
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.
EribulinDrug
Also called E7389
1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.
5-FluorouracilDrug
Also called 5-FU, Adrucil, Efudex
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
EpirubicinDrug
Also called Ellence
100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
CyclophosphamideDrug
Also called Cytoxan, Neosar
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
DoxorubicinDrug
Also called Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF, Adriamycin
50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel + FEC or FAC Group | Experimental | ARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle.
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians. Receives: Drug: Paclitaxel; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Doxorubicin |
| Eribulin + FEC or FAC Group | Experimental | ARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle).
Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians. Receives: Drug: Eribulin; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR)
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.
Measured: 4 -6 weeks from last dose of FAC/FEC-regimen.
Secondary outcomes (2)
5 Year Event Free Survival (EFS)
Event free survival (EFS) the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
Measured: from start of treatment, up to 5 years
Overall Survival (OS)
Measured: from start of treatment, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study start3 Aug 2012
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Vicente Valero, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593020
- Sponsor's protocol ID
- 2012-0167
- Other IDs
- NCI-2012-00851
- Status last verified
- Aug 2021
- First submitted
- 3 May 2012
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01593020
- Acronym / sponsor ID
- 2012-0167
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Early Stage Breast Cancer Not Overexpressing HER-2, Primary invasive adenocarcinoma of the breast, Paclitaxel, Taxol, Eribulin, E7389, 5-Fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- 3 Aug 2012 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 22 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC).
Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die.
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die.
Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.
Detailed description
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.
Eribulin will be provided at no cost to you while you are on this study. You and/or your insurance provider will be responsible for the cost of paclitaxel, doxorubicin, epirubicin, and cyclophosphamide.
Up to 162 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel + FEC or FAC Group | Experimental | Drug: Paclitaxel, Drug: 5-Fluorouracil, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DoxorubicinARM 1: Participants receive Paclitaxel 80 mg/m2 by vein over 1 hour weekly for 12 doses of a 21 day cycle. Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians. |
| Eribulin + FEC or FAC Group | Experimental | Drug: Eribulin, Drug: 5-Fluorouracil, Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DoxorubicinARM 2: Participants receive Eribulin 1.4 mg/m2 by vein over 2-5 minutes on days 1 and 8 every 3 weeks for 4 cycles (21 day cycle). Participants on both arms receive FEC or FAC for 4 cycles (21 day cycle) at the preference of the treating physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed written informed consent
- Histologically confirmed primary invasive adenocarcinoma of the breast.
- Clinical stage breast cancer T2-3, N0-3, M0
- 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).
- 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 treatment. Treatment for DCIS is allowed, such as surgery, hormonal therapy and radiotherapy.
Key exclusion criteria (13 listed)
- Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding.
- Disease free of prior malignancy for < 5 years with the exception of DCIS, curatively treated basal carcinoma of the skin, local skin squamous cell carcinoma, or carcinoma in situ of the cervix.
- Absolute neutrophils count (ANC) < 1500/mm^3
- Total bilirubin > 1.5 times the upper limit of normal (ULN)
- AST or ALT > 2.5 times the upper limit of normal (ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: Taxol80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle. | Drug | Paclitaxel + FEC or FAC Group |
| EribulinAlso: E73891.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle. | Drug | Eribulin + FEC or FAC Group |
| 5-FluorouracilAlso: 5-FU, Adrucil, Efudex500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians. | Drug | Eribulin + FEC or FAC Group, Paclitaxel + FEC or FAC Group |
| EpirubicinAlso: Ellence100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians. | Drug | Eribulin + FEC or FAC Group, Paclitaxel + FEC or FAC Group |
| CyclophosphamideAlso: Cytoxan, Neosar500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians. | Drug | Eribulin + FEC or FAC Group, Paclitaxel + FEC or FAC Group |
| DoxorubicinAlso: Doxorubicin Hydrochloride, Adriamycin PFS, Adriamycin RDF, Adriamycin50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians. | Drug | Eribulin + FEC or FAC Group, Paclitaxel + FEC or FAC Group |
Primary outcome
Pathologic Complete Response (pCR)
Time frame: 4 -6 weeks from last dose of FAC/FEC-regimen.
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.
2 secondary outcomes
5 Year Event Free Survival (EFS)
Time frame: from start of treatment, up to 5 years
Overall Survival (OS)
Time frame: from start of treatment, up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Valero, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Eribulin and 5-Fluorouracil in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) (time frame: 4 -6 weeks from last dose of FAC/FEC-regimen.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.