Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer

NCT02531932 | Completed Phase 2 DMC

• 1 other identifier: GCO 15-1075
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of carboplatin compared to the combination of carboplatin and everolimus for the treatment of advanced triple-negative breast cancer (TNBC). Study close to accrual

Conditions

Breast Cancer

Keywords

advanced triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

• Progress-free survival (PFS)

  The time from the date of randomization to confirmed disease progression or death from any cause, whichever occurs first.

  up to 3 years

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  up to 3 years

• Overall Survival

  up to 3 years

• Clinical Benefit Rate

  up to 3 years

Study Arms (2)

Carboplatin alone

ACTIVE COMPARATOR

AUC 4 every 3 weeks as an IV infusion

Drug: Carboplatin

Carboplatin + Everolimus

EXPERIMENTAL

Carboplatin AUC 4 every 3 weeks IV infusion plus daily oral everolimus 5mg pill

Drug: Carboplatin; Drug: Everolimus

Interventions

Carboplatin DRUG

Carboplatin will be administered if ANC \> 1.0 and platelets are \>75k

Also known as: Paraplatin

Carboplatin + Everolimus; Carboplatin alone

Everolimus DRUG

The study drug Everolimus will be self-administered (by the patients themselves).

Also known as: Certican®, Zortress®, Votubia®

Carboplatin + Everolimus

Eligibility Criteria

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

You may qualify if:

• Women with metastatic breast cancer (measurable or evaluable including bone metastases only)
• Histologically confirmed triple negative breast cancer (ER\< 10%, PR \< 10%, Her2neu IHC 0 or 1 or FISH/ISH negative)
• Age ≥ 18 years
• WHO performance status ≤ 2
• Adequate bone marrow function as shown by: ANC ≥ 1.5 x 10\^9/L, Platelets ≥ 75 x 10\^9/L, Hb \>9 g/dL
• Adequate liver function as shown by:
• serum bilirubin ≤ 1.5 x ULN
• ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
• Adequate renal function: serum creatinine ≤ 1.5 x ULN
• Signed informed consent
• Patients may have had up to 3 prior regimens for metastatic disease
• A baseline CT chest/abdomen/pelvis and bone scan or PET/CT
• Negative serum pregnancy test within 7 days prior to starting treatment
• Stable brain metastases allowed (\> 2 weeks, clinically-stable post treatment with surgery+/-radiation or radiation alone and off steroids)
• Prior carboplatin allowed provided greater than 12 mos have elapsed since last dose of carboplatin

You may not qualify if:

• Patients currently receiving anticancer therapies or who have received anticancer therapies within 2 weeks of the start of study drug (including chemotherapy, radiation therapy, and biologics)
• Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study
• Prior treatment with any investigational drug within the preceding 2 weeks
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior to the first treatment with Everolimus. Topical or inhaled corticosteroids are allowed.
• Co-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP) is prohibited. Co-administration with moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole) or PgP inhibitors may be used with caution and everolimus dosing must be discussed with PI at the time of enrollment. For a current table of Substrates, Inhibitors and Inducers please access the following website:http://www.fda.gov/Drugs/DevelopmentApprovalProcess/"
• Patients who have received live attenuated vaccines within 1 week of start of Everolimus and during the study. Patient should also avoid close contact with others who have received live attenuated vaccines. Examples of live attenuated vaccines include intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella and TY21a typhoid vaccines
• Uncontrolled brain metastases
• Leptomeningeal metastases
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• Symptomatic congestive heart failure of New York heart Association Class III or IV
• unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease
• severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or 02 saturation that is 89% or less at rest on room air
• uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN
• active (acute or chronic) or uncontrolled severe infections

Sponsors & Collaborators

• Amy Tiersten: lead
• Novartis: collaborator

Study Sites (3)

Mount Sinai Downtown

New York, New York, 10011, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carboplatin; Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Sirolimus; Macrolides; Lactones

Study Officials

• Amy Tiersten, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

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: Associate Professor

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 25, 2015
• Study Start: December 16, 2015
• Primary Completion: September 30, 2024
• Study Completion: October 19, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

US (3)