Liposomal Doxorubicin + Carboplatin for Triple-negative Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Mridula George, MD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Stage III-IV cancer, Hypertension, Cardiac disease, others

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This clinical trial aims to evaluate the efficacy, safety, and exploratory measures of liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage triple negative breast cancer (TNBC) patients. The primary objective is to determine the effectiveness of liposomal doxorubicin and carboplatin in reducing the risk of recurrence for early stage TNBC patients. The secondary objectives involve characterizing the safety and toxicity profile of the combination therapy. Adverse events rates will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The exploratory objectives of the study focus on evaluating changes in circulating tumor DNA (ctDNA). This measure will provide insights into the potential utility of ctDNA as a biomarker for treatment response and disease progression. By addressing these objectives, the study aims to contribute to the understanding of the benefits and risks associated with liposomal doxorubicin and carboplatin combination therapy in the adjuvant setting for early stage TNBC, potentially leading to improved treatment outcomes and patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Liposomal Doxorubicin + Carboplatin for Triple-negative Breast Cancer?

Research shows that pegylated liposomal doxorubicin (PLD) is effective for metastatic breast cancer and has less toxicity compared to traditional chemotherapy. Additionally, the combination of PLD and carboplatin is a standard treatment for ovarian cancer, indicating its potential effectiveness in treating other cancers like triple-negative breast cancer.

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Is the combination of Liposomal Doxorubicin and Carboplatin safe for humans?

Liposomal Doxorubicin (PLD) is generally safer than conventional doxorubicin, with less risk of heart damage and hair loss, but it can cause skin issues like hand-foot syndrome and rashes. Combining PLD with Carboplatin may reduce allergic reactions to Carboplatin, and this combination has been studied in various cancers, showing it is generally well-tolerated.

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How does the drug Liposomal Doxorubicin + Carboplatin differ from other treatments for triple-negative breast cancer?

This drug combination uses liposomal doxorubicin, which is a form of the drug doxorubicin enclosed in tiny fat-like particles, making it less toxic and potentially more effective than conventional chemotherapy. It is combined with carboplatin, which is often used in treating other cancers, and this combination is being explored for its safety and effectiveness in treating triple-negative breast cancer.

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Eligibility Criteria

This trial is for early-stage triple-negative breast cancer patients who've had surgery, with tumors under 2.5cm and limited nodal disease. They must understand the study, have not used anthracycline chemo before, and their major organs need to function well. People with advanced cancer, uncontrolled high blood pressure or heart issues, significant medical conditions or infections like HIV/Hepatitis B/C can't join.

Inclusion Criteria

My breast cancer is early stage, triple negative, with a tumor under 2.5cm and minimal to no spread to lymph nodes.

My kidney function is within the required range.

My liver is functioning within the required limits.

Exclusion Criteria

I don't have any health issues that would stop me from joining the study.

I have a serious wound, ulcer, or bone fracture that is not healing.

I have mild to severe numbness or tingling in my hands or feet.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive liposomal doxorubicin and carboplatin every four weeks for four cycles

16 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and changes in ctDNA levels after treatment

5 years

Multiple visits at 6, 12, 18, 24 months and annually up to 5 years

Participant Groups

The OCTANE trial tests a combination of liposomal doxorubicin and carboplatin in patients who've completed primary surgery for early-stage triple-negative breast cancer. It aims to see if this therapy reduces recurrence risk and will also explore changes in circulating tumor DNA as a potential treatment response biomarker.

Group I: Liposomal doxorubicin and Carboplatin Experimental Treatment 1 Intervention

Combination of liposomal doxorubicin 30milligrams per square meter (mg/m2) and carboplatin area under the curve 5 (AUC 5), administered every four weeks for four cycles. Participants with triple-negative breast cancer (TNBC): 1. Completed breast surgery and sentinel lymph node biopsy 2. Tumor size less than2.5 and NO/ N1mi disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

RWJBarnabas Health - Newark Beth Israel Medical Center Newark, NJ

University Hospital-Newark Newark, NJ

RWJBarnabas Health - Trinitas hospital and Comprehensive Center Elizabeth, NJ

RWJBarnabas Health - Monmouth Medical Center Southern Campus Lakewood, NJ

More Trial Locations

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey Lead Sponsor

Mridula George, MD Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynäekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut). [2018] A multicenter non-randomized phase II study was initiated to evaluate tolerability and efficacy of pegylated liposomal doxorubicin (PLD) in combination with carboplatin in gynecologic malignancies.

2. Greece pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin and carboplatin in late-relapsing ovarian cancer: a GINECO group phase II trial. [2018] The GINECO group previously demonstrated that pegylated liposomal doxorubicin (PLD)-carboplatin combination was an effective and well-tolerated treatment for advanced ovarian cancer (AOC) patients in late relapse. The purpose of the present analysis was to confirm these results in a prospective cohort of late-relapsing AOC patients.

3. England pubmed.ncbi.nlm.nih.gov

The role of pegylated liposomal doxorubicin in ovarian cancer: a meta-analysis of randomized clinical trials. [2021] Recent studies suggest that carboplatin with pegylated liposomal doxorubicin (C+PLD) is as efficacious as carboplatin with paclitaxel (C+P) and possibly is more tolerable for ovarian cancer therapy. Pegylated liposomal doxorubicin (PLD) may also be efficacious and tolerable as monotherapy in recurrent or platinum-resistant disease. We performed a meta-analysis of randomized trials in order to elucidate the role of PLD in ovarian cancer.

4. Greece pubmed.ncbi.nlm.nih.gov

Safety and efficacy of pegylated liposomal doxorubicin-based adjuvant chemotherapy in patients with stage I-III triple-negative breast cancer. [2018] Pegylated liposomal doxorubicin (PLD) has been proven to be an effective antitumor drug for metastatic breast cancer, with less toxicity than conventional anthracycline. Our objective was to evaluate the efficacy and safety of PLD-based adjuvant chemotherapy compared to conventional chemotherapy for patients with stages I-III Triple-negative breast cancer (TNBC).

5. United States pubmed.ncbi.nlm.nih.gov

Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. [2019] Carboplatin and pegylated liposomal doxorubicin combination is a standard regimen in platinum-sensitive recurrent ovarian cancer patients. The pegylated liposomal doxorubicin shortage from 2011 to 2013 urged assessment of the efficacy and tolerance of non-pegylated liposomal doxorubicin in combination with carboplatin.

6. England pubmed.ncbi.nlm.nih.gov

Pegylated liposomal doxorubicin (PLD): enhanced skin toxicity in areas of vitiligo. [2022] Pegylated liposomal doxorubicin (PLD, Doxil, Caelyx) is widely used for the treatment of ovarian cancer. It is a stable formulation encapsulating doxorubicin in a 'Stealth' (i.e., pegylated) liposome with a half-life of about 72 hours. This drastically altered pharmacology confers on it a considerably lower risk of cardiotoxicity, no acute emesis, and near absence of alopecia or problems with extravasation necrosis. On the other hand, PLD's dose-limiting toxicity is cutaneous. Since the original phase I report, cutaneous toxicities reported with PLD fall into four common categories: the well known hand-foot syndrome (also called palmoplantar erythrodysesthesia, or PPE), a diffuse follicular rash, intertrigo-like eruption, and hyperpigmentation including melanotic macules.

7. Japan pubmed.ncbi.nlm.nih.gov

Suppressive effect upon carboplatin hypersensitivity reaction via pegylated liposomal doxorubicin combination therapy. [2020] Occurrence of hypersensitivity reaction (HSR) in patients having received multiple doses of carboplatin has been reported. Several studies demonstrated reduction of carboplatin-associated HSR with in combination with pegylated liposomal doxorubicin (PLD). The objective of this study was to determine the suppressive effect on carboplatin-induced HSR via combined treatment with PLD within clinical practice.

8. England pubmed.ncbi.nlm.nih.gov

Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. [2023] This study was designed to demonstrate that efficacy [progression-free survival (PFS)] of CAELYX [pegylated liposomal doxorubicin HCl (PLD)] is non-inferior to doxorubicin with significantly less cardiotoxicity in first-line treatment of women with metastatic breast cancer (MBC).