A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2023
• Main ID: NCT02333370
• Date of registration: 05/01/2015
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
• Scientific title: A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
• Date of first enrolment: February 4, 2015
• Target sample size: 88
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02333370
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Hong Kong, India, Japan, Singapore

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria:

- Women with advanced (locoregionally recurrent or metastatic) breast cancer not
amenable to curative therapy (surgery and/or radiotherapy).

- Patient has a histologically and/or cytologically confirmed diagnosis of estrogen
receptor positive and/or progesterone receptor positive breast cancer

- Patient has HER2-negative breast cancer

- Patient has adequate bone marrow and organ function

Exclusion Criteria:

- Patient who received any CDK4/6 inhibitor.

- Patient has a known hypersensitivity to any of the excipients of LEE011 or letrozole

- Patients with inflammatory breast cancer.

- Patient who received any prior systemic anti-cancer therapy (including hormonal
therapy and chemotherapy) for advanced breast cancer

- Patient is currently using other anti-cancer therapy

- Patient has had major surgery within 14 days prior to starting study drug or has not
recovered from major side effects.

- Patient who has received radiotherapy = 4 weeks

- Patient has a concurrent malignancy or malignancy within 3 years

- Patient has metastases to the central nervous system (CNS).

- Patient has a known history of HIV infection

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Intervention(s)

Drug: goserelin

Drug: Fulvestrant

Drug: LEE011

Drug: Tamoxifen

Drug: Letrozole

Primary Outcome(s)

Phase Ib Dose escalation - Frequency of dose limiting toxicities (DLTs) [Time Frame: first cycle (28 days)]

Phase Ib Dose Expansion: Number of participants with adverse events (AEs) [Time Frame: 18 months]

Phase Ib Dose Expansion: Number of participants with serious adverse events (SAEs) [Time Frame: 18 months]

Secondary Outcome(s)

Composite Plasma pharmacokinetics (PK) parameters of LEE011 (and relevant metabolites) and letrozole - Phase Ib [Time Frame: C1D1, C1D2, C1D8, C1D15, C1D21, C1D22, C2D15, C3D15]

Number of participants with adverse events (AEs) - Phase Ib dose escalation [Time Frame: 18 months]

Number of participants with serious adverse events (SAEs) - Phase Ib dose escalation [Time Frame: 18 months]

Duration of Response (DOR) - Phase Ib dose expansion [Time Frame: 18 months]

Clinical Benefit Rate (CBR) - Phase Ib dose expansion [Time Frame: 18 months]

Disease Control Rate (DCR) - Phase Ib dose expansion [Time Frame: 18 months]

Overall Response Rate (ORR) - Phase Ib dose expansion [Time Frame: 18 months]

Progression Free Survival (PFS) as per RECIST v1.1- phase Ib dose expansion [Time Frame: 18 months]

Overall Survival (OS) - Phase Ib dose expansion [Time Frame: 18 months]

Secondary ID(s)

CLEE011A2115C

Source(s) of Monetary Support

Please refer to primary and secondary sponsors