Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer

NCT02413320 | Completed Phase 2 Results DMC

• 1 other identifier: 2015-IIT-Neoadjuvant-BRST-TNBC
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 9

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.

Conditions

Triple-negative Breast Cancer

Keywords

TNBC, breast cancer, neoadjuvant, carboplatin, docetaxel, paclitaxel, doxorubicin, cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pathological Complete Response

  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. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS.

  20 weeks

Secondary Outcomes (1)

• Number of Participants With Minimal Residual Disease

  20 weeks

Study Arms (2)

Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide

ACTIVE COMPARATOR

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; Drug: Carboplatin; Drug: Doxorubicin; Drug: Cyclophosphamide

Carboplatin + Docetaxel

ACTIVE COMPARATOR

Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles

Drug: Carboplatin; Drug: Docetaxel

Interventions

Paclitaxel DRUG

Also known as: taxol

Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide

Carboplatin DRUG

Also known as: paraplatin

Carboplatin + Docetaxel; Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide

Doxorubicin DRUG

Also known as: adriamycin

Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide

Cyclophosphamide DRUG

Also known as: cytoxin, procytox

Carboplatin + Paclitaxel then Doxorubicin + Cyclophosphamide

Docetaxel DRUG

Also known as: taxotere

Carboplatin + Docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Priyanka Sharma: lead

Study Sites (9)

University of Kansas Cancer Center - CRC

Fairway, Kansas, 66205, United States

Location

Hays Medical Center

Hays, Kansas, 67601, United States

Location

University of Kansas Cancer Center - Overland Park

Overland Park, Kansas, 66210, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Kansas Cancer Center - Westwood

Westwood, Kansas, 66205, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

University of Kansas Cancer Center - South

Kansas City, Missouri, 64131, United States

Location

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

Location

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

Location

Related Publications (1)

• Sharma P, Kimler BF, O'Dea A, Nye L, Wang YY, Yoder R, Staley JM, Prochaska L, Wagner J, Amin AL, Larson K, Balanoff C, Elia M, Crane G, Madhusudhana S, Hoffmann M, Sheehan M, Rodriguez R, Finke K, Shah R, Satelli D, Shrestha A, Beck L, McKittrick R, Pluenneke R, Raja V, Beeki V, Corum L, Heldstab J, LaFaver S, Prager M, Phadnis M, Mudaranthakam DP, Jensen RA, Godwin AK, Salgado R, Mehta K, Khan Q. Randomized Phase II Trial of Anthracycline-free and Anthracycline-containing Neoadjuvant Carboplatin Chemotherapy Regimens in Stage I-III Triple-negative Breast Cancer (NeoSTOP). Clin Cancer Res. 2021 Feb 15;27(4):975-982. doi: 10.1158/1078-0432.CCR-20-3646. Epub 2020 Nov 18.

  PMID: 33208340 RESULT

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Doxorubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Dr. Priyanka Sharma
• Organization: University of Kansas Medical Center

psharma2@kumc.edu

913-588-6029

Study Officials

• Priyanka Sharma, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: May 10, 2021
• Results First Posted: April 30, 2021

Record last verified: 2021-05

Locations

US (9)