CAELYX® as Adjuvant Treatment in Early Stage Luminal B Breast Cancer BREAST CANCER

NCT03712956 | Unknown Phase 2

• 1 other identifier: IEO 0062
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, phase II, single-arm, feasibility study to evaluate PLD (Caelyx®) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer. The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment. Caelyx® should be administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

Conditions

Breast Cancer

Keywords

early breast cancer; luminal B; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of adjuvant PLD (Caelyx®)

  The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment

  4 months

Secondary Outcomes (5)

• Adverse event

  4 months

• percent of patient completing treatment (tolerability)

  4 month

• Breast cancer free interval (BCFI)

  5 years

• Disease Free Survival (DFS)

  5 years

• Overall survival (OS)

  5 years

Study Arms (1)

Caelyx® for 8 courses

EXPERIMENTAL

Caelyx® administered intravenously at a dose of 20 mg/m2 once every two weeks for 8 courses.

Drug: Caelyx®

Interventions

Caelyx® DRUG

Caelyx® every two weeks for 8 courses

Also known as: Caelyx

Caelyx® for 8 courses

Eligibility Criteria

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

You may qualify if:

• Performance status (ECOG) 0-2
• Operable histologically confirmed breast cancer
• Luminal B HER2-negative (ER positive, HER2 negative, and at least one of the following:
• Ki- 67 'high' (≥20%) or PgR 'negative or low') or Luminal B HER2-positive (ER positive, HER2 over-expressed or amplified, any Ki-67, any PgR)
• Early-stage (pT1-3; any nodal status)
• Candidate to adjuvant chemotherapy and endocrine therapy
• The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere
• Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all other criteria are met
• Patients must have had surgery for primary breast cancer with no known clinical residual loco-regional disease
• Margins must be negative for invasive breast cancer and DCIS
• Patients should start treatment as close to definitive surgery as possible (no later than 8 weeks)
• No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is allowed prior to trial entry. Raloxifene, tamoxifen, or other SERM must be discontinued at least 4 weeks before trial entry.
• No hormone replacement therapy (HRT)
• No hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic.
• No treatment with bisphosphonates, except for the treatment of osteoporosis

You may not qualify if:

• Patients with a history of any prior ipsilateral or contralateral invasive breast cancer.
• Patients with previous or concomitant malignancy diagnosed within the past five years. Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma are eligible regardless of the date of diagnosis.
• Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV.
• Patients with myocardial infarction or pulmonary embolism within 6 months prior to trial entry.

Sponsors & Collaborators

• European Institute of Oncology: lead
• Janssen-Cilag International NV: collaborator

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

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

Study Officials

• Elisabetta Munzone, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 19, 2018
• Study Start: March 25, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)