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10627 Background: Anthracyclines (A) are key elements in adjuvant and metastatic chemotherapy regimens for breast cancer. Pre-exposure limits the utilization of A in advanced disease due to cumulative cardiotoxicity. PLD (Caelyx/Doxil) has equivalent activity to conventional doxorubicin in MBC. However PLD has reduced toxicity, including significantly less cardiotoxicity. Combinations of A+C are the backbone of many adjuvant therapies, thus C represents a logical drug to combine with PLD. Methods: MBC patients with measurable disease who completed anthracycline containing adjuvant therapy > 12 months ago were entered in a multi-center single arm phase II trial. They received PLD 35mg/m2 + cyclophosphamide 600 mg/m2 every 3 weeks. This study was powered to demonstrate an objective response rate > 25%. Results: Seventy three patients were enrolled. Prior adjuvant therapy included: AC (37%), CEF/FEC (28%), AC-T (15%), AT (7%), EC (7%). The median cumulative dose of prior A were 240mg/m2 and 580mg/m2 for doxorubicin or epirubicin, respectively. Median time since adjuvant chemotherapy was 4.4 years (1–14). Patients received a median of 6 cycles (2–10) of PLD + C. Major toxicities were; grade 3/4 neutropenia (7.5%), asymptomatic > 10% declines in LVEF (9%) (reversible upon discontinuation of PLD), grade 3/4 hand foot syndrome (6%). Other toxicities were uncommon and usually did not require discontinuation. The objective response rate (ORR) was 38% (4% CR and 34% PR), with an additional 32% having stable disease > 6 months for a clinical benefit of 70% (CB). ORR was similar for patients who had received adjuvant taxanes. Kaplan-Meyer estimated median time to progression was 31.5 weeks (23% progression free). Conclusions: The combination of PLD + C every 3 weeks in patients who have completed adjuvant anthracycline chemotherapy after more than one year prior is well tolerated and has a clinical benefit rate of 70%. This finding is similar to other commonly employed chemotherapeutic regimens for MBC and suggests that re-treatment with a non-cardiotoxic anthracycline following previous anthracycline therapy may be a reasonable therapeutic option for some patients. [Table: see text]