Clinical trial to evaluate the feasibility of pegylated liposomal doxorubicin (Caelyx¿) in women operated for a breast cancer with estrogen receptors expression but either high proliferation rate, or low progesterone receptors expression, or overexpression of HER2.

Phase 1

Active, not recruiting

• Conditions: Operated breast cancer; MedDRA version: 20.0Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000842-30-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

•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 be 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 43
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified