NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer

NCT01931163 | Completed Phase 2 Results

• 3 other identifiers: Pro00008952IRB(2)#0513-0062CRAD001 JUST213
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Everolimus plus Cisplatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: The purpose of this study is to test how effective combining Cisplatin chemotherapy with Everolimus is in treating subjects with triple negative breast cancer who have residual disease after chemotherapy.

Conditions

Breast Cancer; Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Response

  Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

  tumor response at 12 weeks after treatment

Study Arms (1)

Everolimus

EXPERIMENTAL

Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily

Drug: Everolimus

Interventions

Everolimus DRUG

Also known as: RAD001, Afinitor

Everolimus

Eligibility Criteria

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

You may qualify if:

• Female patients ≥18 years of age.
• Clinical/pathological documentation of residual disease after neo-adjuvant therapy.
• Patients with synchronous bilateral cancers are eligible only if:
• Index cancer is triple-negative, defined as ER-, PR-, and HER2-.
• HER2 negative tumors. HER2 negativity must be confirmed by one of the following:
• FISH-negative (FISH ratio \<2.2), or
• IHC 0-1+, or
• IHC 2-3+ AND FISH-negative (FISH ratio \<2.2).
• Estrogen receptor negative and progesterone receptor negative (\<10% staining by IHC for estrogen receptor and progesterone receptor).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Adequate hematologic function, defined by:
• Absolute neutrophil count 2 \>1000/mm3
• Platelet count ≥100,000/mm3
• Hemoglobin \>9 g/dL
• Adequate liver function, defined by:

You may not qualify if:

• Women who are pregnant or breastfeeding.
• History of previously treated ductal carcinoma in situ (DCIS) is acceptable.
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
• Known intolerance or hypersensitivity to Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus);
• Previous cancer (with the exception of non-melanoma skin cancer or cervical carcinoma in situ) in the past 5 years.
• Patients who have any severe and/or uncontrolled medical conditions such as:
• unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to start of Everolimus, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
• Symptomatic congestive heart failure of New York heart Association Class III or IV
• active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
• known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
• active, bleeding diathesis;
• Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• Concurrent severe, uncontrolled infection or intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
• Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• Inability to comply with study and/or follow-up procedures.

Sponsors & Collaborators

• Jenny C. Chang, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (3)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital Willowbrook

Houston, Texas, 77070, United States

Location

Houston Methodist Hospital Sugar Land

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

• Anand K, Patel T, Niravath P, Rodriguez A, Darcourt J, Belcheva A, Boone T, Ensor J, Chang J. Targeting mTOR and DNA repair pathways in residual triple negative breast cancer post neoadjuvant chemotherapy. Sci Rep. 2021 Jan 8;11(1):82. doi: 10.1038/s41598-020-80081-y.

  PMID: 33420229 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Jenny Chang
• Organization: The Methodist Hospital Research Institute

jcchang@houstonmethodist.org

713 441-0680

Study Officials

• Jenny Chang, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: August 29, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: July 20, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-07

Locations

US (3)