Neoadjuvant tratment of patients with stage II - III luminal brest cancer MedDRA version: 14.0 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: Abraxane
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concen
Sponsors
Fundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female patients with histologically confirmed diagnosis of primary unilateral invasive early breast cancer with longest tumor size in breast 2cm, or =65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 1. Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3) 2. Synchronous contralateral or multicentric breast cancer. 3. Clinical or radiologic evidence of metastatic disease. Chest examination by x-ray or CT-scan, abdominal examination by CT-scan, bone examination by bone scan as well as other radiological methods in case of suspicion must be performed before enrollment in order to rule out metastasis. 4. Second primary malignancy, except adequately treated carcinoma in situ of the cervix, stage I colon cancer, non-invasive melanoma, basal or squamous cell carcinomas of the skin, ipsilateral ductal carcinoma in-situ (DCIS) of the breast and lobular carcinoma in-situ (LCIS) of the breast; unless that prior malignancy was diagnosed and definitively treated more than 5 years ago with no subsequent evidence of recurrence. 5. Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies). 6. Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy. 7. Patients with known hypersensitivity to nab-paclitaxel or any of its components. 8. Previous neuropathy grade >1 according to the NCI-CTCAE vs 4.03 criteria 9. Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry. 10. Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator). 11. Patient is pregnant or breast feeding or planning to become pregnant within the six months after the end of treatment. Women with child-bearing potential must be performed a pregnancy serum or urine testing within 7 days prior to study entry according to institutional standards and should use an adequate non-hormonal contraceptive method (intra-uterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterilized) during treatment with study drugs and within the six months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the percentage of patients with poor response [residual cancer burden III (RCB-III) rate] in contrast to good response [residual cancer burden 0/I RCB-0/1] measured by the Symmans criteria [20] at surgery, in patients with stage II-III luminal breast cancer treated with neoadjuvant nab-paclitaxel.; Secondary Objective: -To determine the pathologic complete response (pCR; RCB-0) rate. - To determine de OOR according to RECIST 1.1 measured by MRI and mammogram. - To determine the invasive disease free survival. - To determine the toxicity of this regimen following the NCI CTCAE v 4.03. - To determine de rate of conversion to breast conserving surgery. - To correlate Ki67, gp-60, caveolin-1, SPARC, andother candidate predictive markers of nab-paclitaxel response with efficacy in pre-treatment tumor samples. - To correlate genomic intrinsic subtypes, Luminal and Proliferation meta-genes and single genes determined by PAM50 bioassay, with response. - To determine biomarkers of resistance to nab-paclitaxel in this population - To analyze polymorphisms in genes from pathways that may influence cellular sensitivity to nab-paclitaxel ;Primary end point(s): The primary outcome of the study is the residual cancer burden grade III (RCB-III).;Timepoint(s) of evaluation of this end point: The primary analysis will take place after the last enrolled patient has received surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Analysis for pathological Response Rate - Analysis for objective response - Analysis for vascular response - Analysis for rate of conversion to BCS - Time-to-event Analyses ;Timepoint(s) of evaluation of this end point: After surgery | — |
Countries
Spain
Contacts
Public ContactCesar Rodríguez Martín
Fundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)
Outcome results
None listed