Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
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ClinicalTrials.gov Identifier: NCT02734615 |
Recruitment Status :
Terminated
(Sponsor's decision)
First Posted : April 12, 2016
Last Update Posted : October 11, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced or Metastatic ER+ Breast Cancer | Drug: LSZ102 Drug: LEE011 Drug: BYL719 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 199 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy |
Actual Study Start Date : | June 14, 2016 |
Actual Primary Completion Date : | September 13, 2021 |
Actual Study Completion Date : | September 13, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
Patients will get LSZ102 single agent during dose escalation.
|
Drug: LSZ102
LSZ102 |
Experimental: Arm B
Patients will get LSZ102 in combination with LEE011 during dose escalation.
|
Drug: LSZ102
LSZ102 Drug: LEE011 LEE011
Other Name: ribociclib, Kisqali |
Experimental: Arm C
Patients will get LSZ102 in combination with BYL719 during dose escalation.
|
Drug: LSZ102
LSZ102 Drug: BYL719 BYL719
Other Name: alpelisib |
Experimental: Arm 1
Patients will get LSZ102 single agent during dose expansion
|
Drug: LSZ102
LSZ102 |
Experimental: Arm 2
Patients will get LSZ102 + LEE011 (LEE011 intermittent regimen) during dose expansion
|
Drug: LSZ102
LSZ102 Drug: LEE011 LEE011
Other Name: ribociclib, Kisqali |
Experimental: Arm 3
Patients will get LSZ102 + LEE011 (LEE011 continuous regimen) during dose expansion
|
Drug: LSZ102
LSZ102 Drug: LEE011 LEE011
Other Name: ribociclib, Kisqali |
Experimental: Arm 4
Patient will get LSZ102 in combination with BYL719 during dose expansion
|
Drug: LSZ102
LSZ102 Drug: BYL719 BYL719
Other Name: alpelisib |
- Incidence of dose limiting toxicities (DLTs) [ Time Frame: Day 1 - Day 28 of Cycle 1 (28 day cycle) ]The dose escalation part of the study will be guided by well-established statistical methods/models to estimate the maximum tolerated doses (MTD)and/or recommended doses for expansion (RDE). Safety, pharmacokinetic and pharmacodynamics data will guide dose escalation decisions.
- Safety and tolerability of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719 [ Time Frame: Approximately 3 years ]Incidence and severity of adverse events, serious adverse events, clinical laboratory values, vital signs, ECGs, dose interruptions, dose reductions and dose intensity.
- Overall response rate (ORR) [ Time Frame: Approximately 3 years ]Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719. ORR is defined as the proportion of patients with a best overall response of complete response or partial response.
- Duration of Response (DOR) [ Time Frame: 3 years ]Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719
- Progression Free Survival (PFS) [ Time Frame: 3 years ]Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719
- Disease control rate (DCR) [ Time Frame: 3 years ]Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719
- Plasma concentration of study medications [ Time Frame: 1 cycle (28 day cycle) ]Plasma concentration versus time
- Plasma concentration under fasted condition and fed condition [ Time Frame: Up to 2 cycles (28 day cycle) ]Plasma concentration versus time under fasted and fed conditions
- Levels of Pharmacodynamic marker Estrogen receptor (ER) [ Time Frame: 3 years ]To assess pharmacodynamics effect
- Levels of Pharmacodynamic marker Progesterone receptor (PgR) [ Time Frame: 3 years ]To assess the pharmacodynamic effect
- Levels of Pharmacodynamic marker pS6 [ Time Frame: 3 years ]To assess the pharmacodynamic effect
- Pharmacokinetics (PK) parameter AUC [ Time Frame: 6 cycles (28 day cycle) ]AUC = Area under curve
- PK parameter Cmax [ Time Frame: 6 cycles (28 day cycle) ]Cmax = Maximum observed plasma concentration after drug administration
- PK parameter Tmax [ Time Frame: 6 cycles (28 day cycle) ]Tmax = Time to reach Cmax
- PK parameter Cmin [ Time Frame: 6 cycles (28 day cycle) ]Cmin = Minimum observed plasma concentration after drug administration

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent must be obtained prior to any procedures
- Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer
- Advanced or metastatic breast cancer
- Must be able to swallow tablets and capsules
Exclusion Criteria:
- Symptomatic CNS metastases
- Patients whose laboratory values do not meet protocol criteria
- Clinically significant cardiac disease
- Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications
Other protocol defined inclusion/exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734615
United States, Massachusetts | |
Massachusetts General Hospital Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, Texas | |
MD Anderson Cancer Center SC - LSZ102X2101 | |
Houston, Texas, United States, 77030 | |
Belgium | |
Novartis Investigative Site | |
Bruxelles, Belgium, 1200 | |
France | |
Novartis Investigative Site | |
Lyon Cedex, France, 69373 | |
Germany | |
Novartis Investigative Site | |
Ulm, Germany, 89081 | |
Italy | |
Novartis Investigative Site | |
Milano, MI, Italy, 20133 | |
Novartis Investigative Site | |
Milano, MI, Italy, 20141 | |
Japan | |
Novartis Investigative Site | |
Koto ku, Tokyo, Japan, 135 8550 | |
Singapore | |
Novartis Investigative Site | |
Singapore, Singapore, 169610 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02734615 |
Other Study ID Numbers: |
CLSZ102X2101 2015-004016-38 ( EudraCT Number ) |
First Posted: | April 12, 2016 Key Record Dates |
Last Update Posted: | October 11, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
LSZ102 LEE011 ribociclib Kisqali BYL719 alpelisib ER+ breast cancer advanced ER+ breast cancer metastatic ER+ breast cancer SERD |
SERM fulvestrant tamoxifen aromatase inhibitor ESR1 mtESR1 wtESR1 estrogen receptor endocrine therapy |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |