Trial Outcomes & Findings for Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients (NCT NCT02027376)

NCT ID: NCT02027376

Last Updated: 2023-04-03

Results Overview

DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory values (graded according to the NCI-CTCAE version 4.0) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability to resume dosing for cycles 2 or 3 at the current dose level within 14 days, due to treatment-related toxicity. Dose reductions in cycles 1 and 2 will be considered a DLT

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Up to cycle 2

Results posted on

2023-04-03

Participant Flow

12 patients were enrolled in this trial in the 5 Spanish centers receiving at least one cycle of the combination of oral LDE225 (sonidegib) with intravenous docetaxel. 5 patients were included at Dose Level (DL) 1, 4 patients at DL 2 and 3 patients at DL 3. Two patients at DL 1 and 1 patient at DL 2 were replaced due to early progressive disease.

Two patients at DL 1 and one patient at DL 2 were replaced due to early progressive disease before completing the first 2 cycles.

Participant milestones

Participant milestones
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Overall Study STARTED	5	4	3
Overall Study COMPLETED	4	4	3
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally one a day (QD). Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Overall Study Death	1	0	0

Baseline Characteristics

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LDE225 (Sonidegib) in Combination With Docetaxel n=12 Participants Eligible patients will be included and treated with docetaxel intravenously (75mg/m2) in every three weeks cycles and LDE225 will be administered orally at three dose levels 400, 600 and 800mg QD. Treatment will be repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent. Dose Level 1: 5 patients were included (2 of them were replaced due to progression before completing cycle 2) Dose Level 2: 4 patients were included (1 of them were replaced due to progression before completing cycle 2) Dose Level 3: 3 patients were included
Age, Continuous	49.25 years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Spain	12 participants n=5 Participants
Menopausal status Pre-menopausal	5 participants n=5 Participants
Menopausal status Post-menopausal	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to cycle 2

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=4 Participants Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=3 Participants Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Incidence Rate of DLT Within the First Two Cycles of LDE225 (Sonidegib) in Combination With Docetaxel	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Through study treatment, an average of 2 months

Population: Of the twelve patients included on the study, no Dose Limiting Toxicities (DLTs) were observed at any dose level.

MTD was determined by testing increasing doses of LDE225 on dose escalation cohorts 1 to 6 patients. MTD reflects the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=12 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Maximum Tolerated Dose (MTD) of LDE225 (Sonidegib) in Combination With Docetaxel	800 mg	—	—

PRIMARY outcome

Timeframe: Through study treatment, an average of 2 months

The RP2D was decided by the investigators taken into consideration the information obtained in the study and based on the MTD. To define the RP2D, information about toxicity observed during the full treatment were taken into consideration (relative dose intensity and toxicity observed).

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=12 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Recommended Phase II Dose (RP2D) of LDE225 (Sonidegib) in Combination With Docetaxel	800 mg	—	—

SECONDARY outcome

Timeframe: Through study treatment, an average of 2 months

Safety was assessed by standard clinical and laboratory tests \[vital signs including blood pressure, pulse and body temperature, triplicate 12-lead ECGs at screening and on day 1 of cycle 3, blood tests including hematology (hemoglobin, platelets count, red blood cells (RBC), white blood cells (WBC) with differential count and serum chemistry (serum creatinine, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), creatine phosphokinase (CPK))\]. Adverse events grade were defined by the NCI CTCAE v4.0.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=4 Participants Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=3 Participants Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
The Number of Participants Who Experienced Adverse Events (AE)	5 number of participants with AE	4 number of participants with AE	3 number of participants with AE

SECONDARY outcome

Timeframe: From baseline to cycle 3

Population: Only 6 patients received cycle 3. Results are shown from the predose, at 1 hour and 2 hours post-dose for 6 patients and at 4 hours and 6 hours post-dose for 5 patients.

The QTc intervals have been characterized by comparing QTc at baseline (QTc interval measured in milliseconds (msec) by Fridericia's formula) and at cycle 3 pre-dose, 1 hour post-dose, 2 hours post-dose, 4 hours post-dose and 6 hours post-dose.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=6 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Changes in QT/QTc From Baseline and Cycle 3 ECG Values. Cycle 3, Predose	28.5 milliseconds Interval -26.0 to 82.5	—	—
Changes in QT/QTc From Baseline and Cycle 3 ECG Values. Cycle 3, 1 hour	4.5 milliseconds Interval -15.0 to 23.8	—	—
Changes in QT/QTc From Baseline and Cycle 3 ECG Values. Cycle 3, 2 hours	9.5 milliseconds Interval -5.2 to 24.3	—	—
Changes in QT/QTc From Baseline and Cycle 3 ECG Values. Cycle 3, 4 hours	2.8 milliseconds Interval -23.0 to 29.1	—	—
Changes in QT/QTc From Baseline and Cycle 3 ECG Values. Cycle 3, 6 hours	4.3 milliseconds Interval -15.0 to 23.2	—	—

SECONDARY outcome

Timeframe: Through study treatment, an average of 2 months

Tumor assessments were performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=4 Participants Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=3 Participants Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Time To Progression (TTP)	42.0 days Interval 29.0 to 84.0	42.5 days Interval 20.0 to 64.0	188 days Interval 155.0 to The upper limit of the Confidence Interval (CI) from LDE225 800mg was censored due to one patient discontinued the study treatment due to toxicity and was on Complete Response (CR).

SECONDARY outcome

Timeframe: Up to cycle 2

Population: At LDE225 600 mg, one patient was discontinued after first cycle.

To evaluate the effect of LDE225 on the docetaxel PK, the main pharmacokinetic parameters of docetaxel were estimated on Day 1 of Cycles 1 and 2 of treatment, and compared between them. PK parameters were estimated by non-compartmental approach using Phoenix® WinNonlin® software (version 7.0). In the case of the effect of docetaxel on the LDE225 PK, since patients were always under both drugs at all the assessed PK profiles, the trough LDE225 concentrations obtained in our study were compared with those simulated from a previous developed PK model from LDE225 given as monotherapy. Therefore, a population PK model of LDE225 reported in the literature and developed in healthy subjects and patients with advanced solid tumors was implemented in NONMEN version 7.3 program and Monte-Carlo simulations of LDE225 concentrations after the same doses than those of our study, were performed.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=3 Participants Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=3 Participants Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
LDE225 (Sonidegib) Trough Concentration (Pharmacokinetics (PK))	0.398 mg/L Standard Deviation 0.335	0.392 mg/L Standard Deviation 0.086	0.727 mg/L Standard Deviation 0.539

SECONDARY outcome

Timeframe: Cycles 1 and 2

Population: At LDE225 600 mg, one patient was discontinued after first cycle.

PK sampling of docetaxel was performed on Day 1 of Cycle 1 and 2 of treatment and docetaxel concentrations. Blood samples were collected into ethylenediaminetetraacetic acid (EDTA) K3 tubes and after plasma separation by centrifugation were stored at -70 degrees Celsius until analysis.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=11 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Docetaxel Clearance on Cycle 1 and Cycle 2 (Pharmacokinetics (PK)) Cycle 1 Day 1	48.8 L/h Standard Deviation 19.6	—	—
Docetaxel Clearance on Cycle 1 and Cycle 2 (Pharmacokinetics (PK)) Cycle 2 Day 1	42.7 L/h Standard Deviation 27.8	—	—

SECONDARY outcome

Timeframe: Through study treatment, an average of 2 months

Tumor response was assessed using RECIST 1.1 criteria. The best response across all treatment was recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.

Outcome measures

Outcome measures
Measure	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 Participants Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=3 Participants Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=2 Participants Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally QD. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Objective Response Rate (ORR)	0 Participants	0 Participants	1 Participants

Adverse Events

LDE225 (Sonidegib) 600mg in Combination With Docetaxel

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

LDE225 (Sonidegib) 800mg in Combination With Docetaxel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

LDE225 (Sonidegib) 400mg in Combination With Docetaxel

Serious events: 0 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	LDE225 (Sonidegib) 600mg in Combination With Docetaxel n=4 participants at risk Cohort 2: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 600mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 800mg in Combination With Docetaxel n=3 participants at risk Cohort 3: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 800mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.	LDE225 (Sonidegib) 400mg in Combination With Docetaxel n=5 participants at risk Cohort 1: Eligible patients were included and treated with docetaxel intravenously (75mg/m2) in every 3 weeks cycles and LDE225 400mg was administered orally one a day. Treatment was repeated on day 1 of a 21-day cycle until radiographic or symptomatic progression, unacceptable toxicity or withdraws informed consent.
Injury, poisoning and procedural complications Overdose	25.0% 1/4 • Number of events 1 • Through study treatment, average of 2 months AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.	0.00% 0/3 • Through study treatment, average of 2 months AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.	0.00% 0/5 • Through study treatment, average of 2 months AE were reported after Informed Consent Document (ICD) and before study drugs until approximately 30 days following the discontinuation of study treatment.

Other adverse events

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60