Phase II, open-label, non-randomized study of nab-paclitaxel for the neoadjuvant treatment of patients with stage II and III luminal breast cancer.
- Conditions
- eoadjuvant tratment of patients with stage II - III luminal brest cancerMedDRA 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004476-10-ES
- Lead Sponsor
- Fundación Grupo Español de Investigación en Cáncer de Mama (Fundación GEICAM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 78
1. Female patients with histologically confirmed diagnosis of primary unilateral
invasive early breast cancer with longest tumor size in breast 2cm, or < 2 cm with
axillary involvement. In case of a multifocal tumor (tumor foci located in the same quadrant) the largest lesion must be 2cm (unless axillary involvement) and is
designated as the ?target? lesion for all subsequent tumor evaluations.
2. The breast tumors must be ER positive: more than 1% of stained tumor cells by IHC, and HER2 negative: 0, or 1+ score by IHC, or 2+ with FISH/CISH negative for
HER2 amplification (defined as a ratio of HER-2/neu copies to chromosome 17
centromere (CEP17) signals <1.8), according to the local laboratory).
3. Are clear candidates to receive chemotherapy by the investigator criteria.
4. Are at least 18 years of age.
5. Have at least one unidimensionally measurable lesion by RECIST version 1.1,
measured by mammogram.
6. Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) <2
7. Have adequate renal and liver function and bone marrow reserve as follows:
? Bone marrow: ANC ³ 1.500/mm3 (1.5 x 109/L); platelet count ³ 100.000/mm3
(100.0 x 109/L); and hemoglobin ³ 9 g/dL.
? Hepatic: bilirubin £1.5 times the upper limit of normal (x ULN); alkaline
phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase
(ALT) £2.5 × ULN and Albumin 2.5 g/dL.
? Renal: serum creatinine <1.5 x ULN.
8. Exhibit patient compliance and geographic proximity that allow for adequate followup
9. Entry informed consent form signed by the patient.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method