Breast cancer MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: SANDRENA*GEL 91CONT MONO 0,5G
Pharmaceutical Form: Gel
INN or Proposed INN: ESTRADIOL HEMIHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal women with operable breast cancer - Patient with diagnosis of histological proven breast cancer (pT1, pT2, or pT3, N sentinel negative, pN0(either i- or i+); M0. - Diagnosis of hormone receptor positive tumors. (ER and/or PgR must be greater than or equal to 10%) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Patients who are premenopausal - Patients with locally advanced disease (pN1, pN2, pN3) or distant metastatic disease - Patients with bilateral invasive breast cancer - Patients with positive final margins (referring to only DCIS and invasive cancer, not LCIS). - Patients with a history of prior ipsilateral or contralateral invasive breast cancer. - Patients with previous or concomitant malignancy EXCEPT adequately treated (basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma). - Patients who have received prior therapy for breast cancer including prior irradiation, adjuvant or neoadjuvant chemotherapy or endocrine therapy. - Patients who were taking tamoxifen or other SERM (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the increase (a 50% increase) in serum Estradiol levels after 3-month estradiol treatment.;Secondary Objective: • To evaluate patient-reported outcomes (PRO) in terms of symptoms related to endocrine treatment and two global quality of life (QoL) indicators. • To evaluate the change in the biochemical marker of bone turnover modification C-telopeptide (C-terminal telopeptide of the 1 chain of type I collagen (CTX)), after 3-month estradiol treatment. • To evaluate breast cancer related free survival (BCRS), disease free survival (DFS), and overall survival (OS). • To compare the results of this study to the results of our previous study on 3-month letrozole therapy free interval.;Primary end point(s): serum Estradiol levels after 3-month estradiol treatment.;Timepoint(s) of evaluation of this end point: at baseline and after 3 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • patient-reported outcomes (PRO) in terms of symptoms related to endocrine treatment and two global quality of life (QoL) indicators. • variations of biochemical marker of bone turnover modification C-telopeptide (C-terminal telopeptide of the 1 chain of type I collagen (CTX)), after 3-month estradiol treatment. • breast cancer related free survival (BCRS), disease free survival (DFS), and overall survival (OS).;Timepoint(s) of evaluation of this end point: For Quality of Life: 24 months For C-tepoleptide marker evaluation: 15 months For BCRS, DFS, OS evaluation: ongoing | — |
Countries
Italy
Contacts
Public ContactUfficio studi clinici
Istituto Europeo Oncologia
Outcome results
None listed