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Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer (NeoSTOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02413320
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Priyanka Sharma, University of Kansas Medical Center

Brief Summary:
Evaluate if the two carboplatin containing chemotherapy regimens will reduce the growth of breast cancer cells in women with Stage I, II, or III triple negative breast cancer.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Drug: Paclitaxel Drug: Carboplatin Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel Phase 2

Detailed Description:

Sporadic and germline BRCA mutation associated triple-negative breast cancer share several pathological and molecular similarities which have led to the exploration of DNA damaging agents like platinum compounds in patients with triple-negative breast cancer. Recent studies demonstrate that addition of neoadjuvant carboplatin to doxorubicin/cyclophosphamide/taxane-based chemotherapy improves pathological complete response in patients with stage I-III triple-negative breast cancer but also increase toxicity.

A recent study reported encouraging pathological complete response rates with a non-anthracycline carboplatin plus docetaxel neoadjuvant chemotherapy regimen in a cohort of 49 triple negative breast cancer patients. This chemotherapy regimen of carboplatin plus docetaxel yielded an overall pathological complete response rate of 65% in unselected triple-negative breast cancer with pathological complete response rates of 61% in sporadic and 77% in germline BRCA-associated triple-negative breast cancer. The chemotherapy regimen of carboplatin/docetaxel is well tolerated and should be studied further and compared with regimens that add carboplatin to the standard anthracycline/taxane containing regimens.

This is the basis for the proposed randomized neoadjuvant phase II study to further estimate and compare pathological complete response rates of carboplatin plus docetaxel x 6 cycles to carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide x 4 cycles in stage I-III triple negative-breast cancer.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Open Label Phase II Trial of Neoadjuvant Carboplatin Plus Docetaxel or Carboplatin Plus Paclitaxel Followed by Doxorubicin Plus Cyclophosphamide in Stage I-III Triple-negative Breast Cancer
Study Start Date : July 2015
Actual Primary Completion Date : February 1, 2019
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
Drug: Paclitaxel
Other Name: taxol

Drug: Carboplatin
Other Name: paraplatin

Drug: Doxorubicin
Other Name: adriamycin

Drug: Cyclophosphamide
Other Name: cytoxin, procytox

Active Comparator: Carboplatin + Docetaxel
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
Drug: Carboplatin
Other Name: paraplatin

Drug: Docetaxel
Other Name: taxotere




Primary Outcome Measures :
  1. Pathological complete response rates [ Time Frame: 20 weeks ]
    To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer.


Secondary Outcome Measures :
  1. Minimal residual disease rates [ Time Frame: 20 weeks ]
    To evaluate minimal residual disease rates with two neoadjuvant chemotherapy regimens in subjects with stage I-III triple-negative breast cancer.


Other Outcome Measures:
  1. Pathological complete response and minimal residual disease rates in germline BRCA associated and BRCA wild type triple-negative breast cancer [ Time Frame: 20 weeks ]
    Compare pathological complete response and minimal residual disease rates in subjects with germline BRCA associated and BRCA wild type triple-negative breast cancer with the two neoadjuvant chemotherapy regimens.

  2. Difference in cost associated with two chemotherapy regimens to treat triple-negative breast cancer [ Time Frame: 20 weeks ]
    Assessment of cost associated with the delivery of the two chemotherapy regimens.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed stage I (T>1cm), II or III triple negative breast cancer who have not had definitive breast surgery or received systemic chemotherapy
  • The invasive tumor must be hormone receptor-poor, defined as both estrogen receptor and progesterone receptor staining present in ≤ 10% of invasive cancer cells by Immunohistochemistry.
  • HER- 2 negativity will be based on the current ASCO-CAP guidelines for HER testing
  • No prior chemotherapy, endocrine therapy or radiation therapy with therapeutic intent for this cancer
  • Female subjects age 18 - 70 years
  • ECOG Performance Status of 0-1
  • Adequate organ and marrow function as defined below:

    • Leukocytes ≥ 3,000/uL
    • Absolute neutrophil count ≥ 1500/uL
    • Platelets ≥ 100,000/uL
    • Total bilirubin ≤ 1.5mg/dL
    • AST(SGOT)/ALT(SPGT) ≤ 2 x institutional upper limit of normal
    • Creatinine ≤ 1.5mg/dl and/or Creatinine Clearance ≥ 60mL/min
    • Serum albumin ≥ 3.0 g/dL
  • Women of child-bearing potential must agree to use adequate contraception
  • Pretreatment lab values must be performed within 14 days of treatment initiation, and other baseline studies performed within 30 days prior to registration
  • Subjects should have LVEF ≥ 50% by echocardiogram or MUGA scan performed within 4 weeks prior to treatment initiation
  • Subjects should have breast and axillary imaging with breast MRI or breast and axillary ultrasound within 4 weeks prior to treatment initiation
  • Subjects with clinically/radiologically abnormal axillary lymph nodes should have pathological confirmation of disease with image guided biopsy/fine needle aspiration.
  • Subjects must be already enrolled in P.R.O.G.E.C.T observational registry
  • Staging to rule out metastatic disease is recommended for subjects with clinical stage III disease
  • Subjects with bilateral disease are eligible if they meet other eligibility criteria.
  • Neuropathy: No baseline neuropathy grade > 2

Exclusion Criteria:

  • Current or anticipated use of other investigational agents
  • Subject has received chemotherapy, radiotherapy or surgery for the treatment of breast cancer
  • Subject with metastatic disease
  • History of allergic reactions to compounds of similar chemical or biologic composition to carboplatin, docetaxel, doxorubicin, cyclophosphamide, paclitaxel, or other agents used in the study
  • Subjects with inflammatory breast cancer
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Subject is pregnant or nursing
  • Subjects with concomitant or previous malignancies within the last 5 years. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
  • Ejection Fraction <50% on ECHO or MUGA
  • Cardiac function: Subjects with congestive heart failure, myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke or transient ischemia attack within the past 12 months, uncontrolled hypertension (Systolic BP>160 or Diastolic BP>90), uncontrolled or symptomatic arrhythmia, or grade ≥ 2 peripheral vascular 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): NCT02413320


Locations
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United States, Kansas
University of Kansas Cancer Center - CRC
Fairway, Kansas, United States, 66205
Hays Medical Center
Hays, Kansas, United States, 67601
University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States, 66210
Salina Regional Health Center
Salina, Kansas, United States, 67401
University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States, 66205
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
University of Kansas Cancer Center - South
Kansas City, Missouri, United States, 64131
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Sponsors and Collaborators
Priyanka Sharma
Investigators
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Principal Investigator: Priyanka Sharma, MD University of Kansas Medical Center

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Responsible Party: Priyanka Sharma, Medical Doctor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02413320    
Other Study ID Numbers: 2015-IIT-Neoadjuvant-BRST-TNBC
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Priyanka Sharma, University of Kansas Medical Center:
TNBC, breast cancer, neoadjuvant, carboplatin, docetaxel, paclitaxel, doxorubicin, cyclophosphamide
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Doxorubicin
Liposomal doxorubicin
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