Breast Cancer
Conditions
Brief summary
The trial investigates the effect of oral supplement of molecular iodine (I2) alone and in combination with 4 to 6 cycles of FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) treatment in woman diagnosticated with early (stage II) and advance (stage III) breast cancer, respectively. The study analyzes the clinical response \[tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).
Detailed description
The leading causes of failure of breast cancer treatment are the rapid development of metastases and tumor resistance to antineoplastic drugs. Anthracyclines (doxorubicin (DOX), epirubicin, etc.) are the golden standard in neoadjuvant therapy and are commonly used in the FEC/TE (5-fluorouracil, epirubicin, cyclophosphamide/taxotere, epirubicin) combination therapy during advanced breast cancer. However, even when treated with this potent chemotherapeutic combination, 30% of patients develop chemoresistance and cardiomyopathic side effects. Previous studies support that the oral supplement of molecular iodine (I2) exerts synergistic antineoplastic and cardioprotective impact when used in combination with the DOX in rodent and canine mammary cancer model. The present study performed two randomized clinical groups including women with early (stage II) and advanced (stage III) breast cancer. In the Early group, women were treated with I2 (5 mg/day) or placebo (colored water) for 7 to 35 days. In the Advanced group, patients received treatment (I2 or placebo) along with 4 to 6 cycles of FEC/TE treatment. The study analyzes the clinical response \[tumor size, thyroid status, side effects (Common Toxicity Criteria V4.0)\] and molecular mechanisms in the tumor samples (transcriptomic, proteins and immune responses).
Interventions
DRUGPlacebo
Selected patients with early breast cancer (stage II) non-pretreated received colored water solution (placebo) within the time before the hospital assigned them to her surgery (7 to 35 days).
DRUGiodine
Selected patients with early breast cancer (stage II) non-pretreated received iodine solution (Experimental) within the time before the hospital assigned them to her surgery (7 to 35 days).
DRUGFEC/TE Placebo
The selected patients with advanced breast cancer (stage III) non-pretreated received colored water solution (placebo) within the time of oncology designed chemotherapy treatment FEC/TE (4 or 6 cycles/ every 21 days).
DRUGFEC/TE iodine
The selected patients with advanced breast cancer (stage III) non-pretreated received iodine solution (experimental) within the time of oncology designed chemotherapy treatment (4 or 6 cycles/ every 21 days).
Sponsors
Hospital General Regional #1 IMSS, Queretaro México
Clínica Hospital Dr. Ismael Vázquez Ortiz ISSSTE, Queretaro Mexico
Hospital Medico TEC100, Queretaro México
Universidad Nacional Autonoma de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double blind
Intervention model description
two randomized clinical groups including women with early (stage II) and advanced (stage III) breast cancer. In the Early group, women were treated with I2 (5 mg/day) or placebo (colored water) for 7 to 35 days. In the Advanced group, patients received treatment (I2 or placebo) along with 4 to 6 cycles of FEC/TE treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 81 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed, stage II or III breast cancer * Scheduled to surgical of the primary tumor (stage II) * Will receive neoadjuvant FEC/TE chemotherapy (stage III). * age \> 18 and \< 81 years * Non-pregnant * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Known sensitivity to iodine or FEC/TE * Concurrent severe and/or uncontrolled disease * Myocardial infarction within the last six months before the study * Unstable or uncontrolled hypertension * Thyroid dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor classification type and modification after treatment | 40 minutes | Estrogen receptor (ER), Progesterone receptor (PR) and Human epidermal growth factor receptor 2 (HER2) presence in biopsy (initial) and tumor sample after treatments (final) by immunohistochemical method (number of positive cells/field). |
| Tumor response [change in size] | 20 minutes | The size of the tumor is calculated by measuring the largest diameter of the tumor in the axial plane. The first measurement is obtained in the mammography taken before the start of the protocol and the second measurement is made on the tissue after surgery. The change percentage is obtained by dividing the final size between the initial size by 100. |
| Incidence of treatment-emergent adverse events [Safety and Tolerability]). | 40 minutes | Presence or not of: Edema, hand-foot syndrome, anorexia, vomiting, diarrhea, nausea, asthenia (patient interview and clinical auscultation) |
| Differential Blood Count | 10 minutes (duration of blood withdrawal)] | Differential blood count gives relative percentage of each type of white blood cell and helps reveal abnormal white blood cell populations (eg, blasts, immature granulocytes, or circulating mature cells in the peripheral blood). |
| Thyroid Test | 10 minutes (duration of blood withdrawal) | Serum quantification of thyroxine, triiodothyronine, and thyroid stimulating hormone (nmol/ml) by ELISA Method |
| Cardiac damage | 10 minutes (duration of blood withdrawal) | Measurement of creatine kinase myocardial band (CK-MB) concentration in serum (ImU/ml) by Colorimetric Method. |
| Iodine consumes | 10 minutes (duration of urine recollection) | Measurement of iodine concentration in urine (ug/mL) by Ion Chromatography Method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | Every 6 months for 5 years | The follow-up of the disease-free survival (DFS) at 5 years. (patient interview and clinical auscultation each six months) |
Countries
Mexico
Contacts
Primary ContactCarmen Aceves, PhD
Outcome results
None listed