Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Nab-paclitaxel
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoadjuvant nab-paclitaxel luminal breast cancer

Summary:

      Multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of
      nab-paclitaxel in the neoadjuvant treatment of ER positive human epidermal growth factor
      receptor 2 (HER2) negative patients amenable to receive neoadjuvant chemotherapy.
    

Eligibility 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 < 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
             immuno-histochemistry (IHC), and HER2 negative: 0, or 1+ score by IHC, or 2+ with
             fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH)
             negative for HER2 amplification (defined as a ratio of HER2/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 [65] 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: absolute neutrophil count (ANC) > or = 1.500/mm3 (1.5 x 109/L);
                  platelet count > or = 100.000/mm3 (100.0 x 109/L); and hemoglobin > or = 9 g/dL.

               -  Hepatic: bilirubin < or = 1.5 times the upper limit of normal (x ULN); alkaline
                  phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) <
                  or = 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 follow-up

          9. Entry informed consent form signed by the patient.

        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.