Clinical trial NCT02802748 (early phase 1, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: oral vinorelbine, letrozole
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent for all study procedures in accordance with local regulatory
             requirements before protocol-specific procedures are started.

          -  Postmenopausal status

          -  Histologically confirmed invasive breast carcinoma, with all of the following
             characteristics: Primary tumor greater than or equal to (>/=) 1cm in largest diameter
             (cT1-3) and N0-Stage I to operable Stage III breast cancer

          -  Scheduled or possibility of scheduling primary surgery within study window (surgery or
             biopsy within 5 days after treatment completion)

          -  HR-positive breast cancer defined as ≥1% of anti-ER and/or anti-PgR stained tumor
             cells by IHC (per local assessment)

          -  HER2-negative BC by IHC (score 0 or 1+) and/or FISH/CISH/SISH (defined as a ratio of
             HER2/CEP17<2 or single-probe average HER2 copy number <4 signals/cell), as per local
             assessment.

          -  Known percentage of Ki67-positive tumor cells within pre-treatment sample or
             possibility of local assessment.

          -  Available pre-treatment core or possibility to take a new biopsy with enough tumor
             sample for study analysis

          -  ECOG performance status of 0 or 1

          -  Adequate organ function, determined by laboratory tests performed within 7 days before
             treatment start

        Exclusion Criteria:

          -  Patients with cT4 or cN2-3 stage breast tumors

          -  Bilateral invasive, multicentric or metastatic breast cancer

          -  Patients with prior excisional biopsy of primary tumor and/or of axillar lymph nodes
             or or sentinel lymph node biopsy

          -  Patients for whom upfront chemotherapy is clinically judged appropriate as optimal
             neoadjuvant treatment

          -  Patients requiring imminent surgical procedure

          -  Any prior treatment for breast cancer except for patients with Lobular Carcinoma In
             Situ (LCIS) treated with surgery or with Ductal Carcinoma In Situ (DCIS) treated
             exclusively with mastectomy. In both cases, surgery must have taken place >5 years
             prior diagnosis of current breast cancer

          -  Other concurrent secondary malignancies, except for appropriately treated non-melanoma
             skin carcinoma, in situ melanoma and/or in situ cervical/colon cancer

          -  Treatment with any investigational medicinal product or participation in another
             therapeutic clinical trial concurrently or in the 28 days prior randomization

          -  Current uncontrolled severe systemic disease that could interfere with the intended
             therapy (e.g. clinical significant cardiovascular disease, pulmonary or metabolic
             disease, wound healing disorders, severe infection, heart failure, ischemic heart
             disease)

          -  Hereditary fructose intolerance

          -  Major surgical procedure or significant traumatic lesion within 28 days prior to
             treatment allocation or anticipated need for major surgery during the course of the
             study treatment, except if related with the breast cancer

          -  Any psychological, family, sociological or geographical circumstance that could
             potentially represent an obstacle to compliance with the study protocol and the
             follow-up schedule; these circumstances will be discussed with the patient before
             enrolment in the trial