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A Phase II Study of Using Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen (AC) for New Triple-Negative Inflammatory Breast Cancer (TN-IBC)

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ClinicalTrials.gov Identifier: NCT02876107
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if adding panitumumab to the combination of carboplatin and paclitaxel can help to control IBC when given before other standard chemotherapy and surgery. The safety of these drug combinations will also be studied.

This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. Paclitaxel, carboplatin, doxorubicin and cyclophosphamide are FDA approved and commercially available for the treatment of breast cancer. The addition of panitumumab to the combination of carboplatin and paclitaxel is investigational and currently being used for research purposes only. The study doctor can describe how the study drugs are designed to work.

Up to 72 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Breast Procedure: Breast Core Biopsy Drug: Paclitaxel Drug: Carboplatin Drug: Panitumumab Drug: Doxorubicin Drug: Cyclophosphamide Procedure: Mammogram Procedure: Ultrasound Other: Follow Up Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Neoadjuvant Carboplatin/Paclitaxel (CT) Versus Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen for Newly Diagnosed Primary Triple-Negative Inflammatory Breast Cancer
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024


Arm Intervention/treatment
Experimental: PaCT + Doxorubicin and Cyclophosphamide.

Participants receive panitumumab, carboplatin, and paclitaxel (PaCT) followed by doxorubicin and cyclophosphamide.

Breast core biopsy performed before Day 1 of Cycle 1 for biomarker testing.

Paclitaxel given by vein on Days 1, 8, and 15 of Cycles 1-4. Carboplatin given by vein on Day 1 of Cycles 1-4. Panitumumab by vein on Day 1 of a 1-week "pre-cycle." Participants then receive it on Days 1, 8, and 15 of Cycles 1-4, before paclitaxel.

Doxorubicin and cyclophosphamide given by vein on Day 1 of Cycles 5-8.

Study cycle is 21 days.

Before receiving doxorubicin and cyclophosphamide, mammogram of the involved breast and an ultrasound of the involved breast and lymph nodes performed.

Study staff checks on participant about 1 month after surgery, and once each year for at least 5 years after participant stops taking the study drugs.

Procedure: Breast Core Biopsy
Breast core biopsy performed before Day 1 of Cycle 1 for biomarker testing.

Drug: Paclitaxel
80 mg/m2 given by vein on Days 1, 8, and 15 of Cycles 1-4.
Other Name: Taxol

Drug: Carboplatin
5 AUC given by vein on Day 1 of Cycles 1-4.
Other Name: Paraplatin

Drug: Panitumumab
2.5 mg/kg by vein on Day 1 of a 1-week "pre-cycle." Participants then receive it on Days 1, 8, and 15 of Cycles 1-4, before paclitaxel.
Other Name: Vectibix

Drug: Doxorubicin
60 mg/m2 given by vein on Day 1 of Cycles 5-8.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Cyclophosphamide
600 mg/m given by vein on Day 1 of Cycles 5-8.
Other Names:
  • Cytoxan
  • Neosar

Procedure: Mammogram
Before receiving doxorubicin and cyclophosphamide, a mammogram of the involved breast performed.

Procedure: Ultrasound
Before receiving doxorubicin and cyclophosphamide, an ultrasound of the involved breast and lymph nodes performed.

Other: Follow Up
Study staff checks on participant about 1 month after surgery, and once each year for at least 5 years after participant stops taking the study drugs.

Experimental: CT + Adriamycin and Cyclophosphamide (AC)

Participants receive carboplatin and paclitaxel (CT) followed by doxorubicin and cyclophosphamide (AC).

Paclitaxel given by vein on Days 1, 8, and 15 of Cycles 1-4. Carboplatin given by vein on Day 1 of Cycles 1-4.

Doxorubicin and cyclophosphamide given by vein on Day 1 of Cycles 5-8.

Study cycle is 21 days.

Before receiving doxorubicin and cyclophosphamide, mammogram of the involved breast and an ultrasound of the involved breast and lymph nodes performed.

Study staff checks on participant about 1 month after surgery, and once each year for at least 5 years after participant stops taking the study drugs.

Drug: Paclitaxel
80 mg/m2 given by vein on Days 1, 8, and 15 of Cycles 1-4.
Other Name: Taxol

Drug: Carboplatin
5 AUC given by vein on Day 1 of Cycles 1-4.
Other Name: Paraplatin

Drug: Doxorubicin
60 mg/m2 given by vein on Day 1 of Cycles 5-8.
Other Names:
  • Doxorubicin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Cyclophosphamide
600 mg/m given by vein on Day 1 of Cycles 5-8.
Other Names:
  • Cytoxan
  • Neosar

Procedure: Mammogram
Before receiving doxorubicin and cyclophosphamide, a mammogram of the involved breast performed.

Procedure: Ultrasound
Before receiving doxorubicin and cyclophosphamide, an ultrasound of the involved breast and lymph nodes performed.

Other: Follow Up
Study staff checks on participant about 1 month after surgery, and once each year for at least 5 years after participant stops taking the study drugs.




Primary Outcome Measures :
  1. Complete Pathologic Response (pCR) Rate [ Time Frame: After 8 cycles. Each cycle is 21 days. ]
    pCR assessed at the time of surgery. Breast tissue samples collected during surgery. A Chi-square test or Fisher's exact test used to compare the differences in pCR rate between the two treatment arms.


Secondary Outcome Measures :
  1. Disease-Free Survival (DFS) Rate [ Time Frame: 5 years ]
    Disease progression defined as rapid growth of multiple measurable, non-measurable, or new lesions, or at least a 20% increase in the sum of diameters of target (measurable) lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histological confirmation of breast carcinoma.
  2. Patients must have IBC, confirmed according to international consensus criteria: a. Onset: Rapid onset of breast erythema, edema, and/or peau d'orange, and/or warm breast, with or without an underlying breast mass b. Duration: History of such findings no more than 6 months c. Extent: Erythema occupying at least 1/3 of whole breast d. Pathology: Pathologic confirmation of invasive carcinoma
  3. Patients must have an ECOG performance status of 0-1.
  4. Patients must have negative HER2 expression on IHC (defined as 0 or 1+) or FISH analysis. If HER2 is 2+, negative HER2 expression must be confirmed by FISH (HER2/cep17 ration <2, and/or copy number less than 6). ER and PgR expression should be less than 10%.
  5. Patients must be 18 years of age or older.
  6. Patients have LVEF >=50% by multigated acquisition scan (MUGA) or echocardiogram before study randomization
  7. Patients have adequate hematologic function: absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count >=100 x 10^9/L, hemoglobin >= 9.0 g/dL.
  8. Patients have adequate hepatic function: aspartate aminotransferase (AST) =<3.0 x ULN, alanine aminotransferase (ALT) =< 3.0 x ULN, alkaline phosphatase (ALP) =< 2.5 x ULN, total bilirubin =<1.5 x ULN
  9. Patients have adequate renal function: creatinine (Cr) =< 1.5 mg/dL x ULN, creatinine clearance (CrCl) >= 50 mL/min calculated by the Cockcroft-Gault method as follows: male creatinine clearance = (140 - age in years) x (weight in kg) / (serum Cr x 72); female CrCl = (140 - age in years) x (weight in kg) x 0.85 / (serum Cr x 72).
  10. Patients have the ability and willingness to sign written informed consent.
  11. Patients of childbearing potential (women who are postmenopausal for <1 year, not surgically sterilized, or not abstinent), have a negative urine pregnancy test, and agree to the consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile before the female subject's entry into the study and is the sole sexual partner for that female subject; intrauterine device, oral contraception, or barrier methods, including diaphragm or condom with a spermicide

Exclusion Criteria:

  1. Stage IV disease, if the metastatic sites are not amendable for local therapy (i.e. radiation and/or surgery), and are not candidates for breast surgery will not be eligible.
  2. History of radiotherapy for current breast cancer diagnosis.
  3. History of recent malignancies <5 years (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ)
  4. Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection.
  5. History of extensive interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest CT scan.
  6. Other known other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  8. Patients with a peripheral neuropathy > grade 1.
  9. Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina, or CVA within 6 months of protocol registration.
  10. Patients have a history of prior therapy with carboplatin.
  11. Patients have received a cumulative dose of doxorubicin of greater than 360 mg/m2 or epirubicin of greater than 640 mg/m2.
  12. Patients have had prior radiotherapy for primary breast carcinoma or axillary lymph nodes.
  13. Patients have history of diagnosed interstitial lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876107


Contacts
Contact: Naoto Ueno, MD, PHD 713-792-2817

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Amgen
Investigators
Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02876107     History of Changes
Other Study ID Numbers: 2016-0177
NCI-2017-00619 ( Registry Identifier: NCI CTRP )
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Malignant neoplasm of breast
Breast cancer
Newly diagnosed primary triple-negative inflammatory breast cancer
Inflammatory breast cancer
Breast biopsy
IBC
TN-IBC
Mammogram
Ultrasound
Paclitaxel
Taxol
Carboplatin
Paraplatin
Panitumumab
Vectibix
Doxorubicin
Doxorubicin Hydrochloride
Adriamycin PFS
Adriamycin RDF
Adriamycin
Rubex
Cyclophosphamide
Cytoxan
Neosar

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors