Neoadjuvant Treatment With Nab-paclitaxel for Patients With Stage II and III Luminal Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT01565499
First received: March 22, 2012
Last updated: June 7, 2013
Last verified: November 2012
  Purpose

Study GEICAM 2011-02 is a multicenter, open label, non-randomized phase 2 trial to evaluate the efficacy and safety of nab-paclitaxel in the neoadjuvant treatment of ER positive HER2 negative patients amenable to receive neoadjuvant chemotherapy.

The primary objetive of the trial is 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.

The primary endpoint of the study is to determine the residual cancer burden grade III (RCB-III) after surgery.

The total number of patients to be included in this study is 78 patients.

The duration of the study, from first patient visit to last patient visit will be approximately 90 months (Including follow-ups)


Condition Intervention Phase
Breast Cancer
Drug: Nab-paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Open-label, Non-randomized Study of Nab-paclitaxel for the Neoadjuvant Treatment of Patients With Stage II and III Luminal Breast Cancer

Resource links provided by NLM:


Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • The residual cancer burden grade III (RCB-III). [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]

    The RCB-III will be reported, including a 95% confidence interval. The estimate of the RCB-III will be calculated as follows:

    Overall Response Rate = Number of patients with RCB-III / ITT population



Secondary Outcome Measures:
  • Analyses for pathological Response Rate [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]
    The pCR (RCB-0) rate will be reported including a 95% confidence interval. The estimate of the pCR rate will be calculated as follows: pCR Rate = Number of patients with pCR / ITT population. Additional exploratory analysis will be performed calculating the rate of RCB-0 + RCB-I.

  • Analyses for objective response [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]

    The ORR will be reported, including a 95% confidence interval. The estimate of the ORR will be calculated as follows:

    Overall Response Rate = Number of CRs, PRs / ITT population


  • Analyses for rate of conversion to BCS [ Time Frame: After the last enrolled patient has recieved surgery (Around 29 months since the beginning of the study) ] [ Designated as safety issue: No ]

    The conversion from the initially planned mastectomy to BCS will be reported including a 95% confidence interval. The estimate of the rate of conversion to BCS will be calculated as follows:

    BCS rate = Number of patients with BCS / Number of patients with initially planned mastectomy.


  • Time-to-event Analyses [ Time Frame: Death or up to 5 years whatever occurs first for each patient ] [ Designated as safety issue: No ]
    Invasive Disease Free Survival will be evaluated. It is defined as the time (days)from the date of randomization until the date of objective recurrent disease (local, regional or distant), second primary invasive malignancy (breast or non-breast) or death from any cause. For patients not known to have died as of the data cut-off date and who do not have recurrent disease or second primary tumor, invasive disease-free survival will be censored at the last contact date. DCIS will not be considered an event for the purpose of this analysis, but will be collected in the e-CRF.

  • Toxicity and tolerability of nab-paclitaxel analysis. [ Time Frame: During treatment and until 30 days after the last dose of each patient study treatment ] [ Designated as safety issue: Yes ]

    Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010) that occur during the study treatment period or within 30 days of the last dose of study treatment, regardless of causality and according to the relationship to study drug as assessed by the investigator, will be collected and evaluated. Additionally, the following safety-related outcomes will be summarized:

    • study treatment discontinuations due to adverse events.
    • deaths
    • SAEs
    • hospitalizations and transfusions
    • use of key concomitant medications or growth factors


Estimated Enrollment: 78
Study Start Date: June 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nab-paclitaxel
    The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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 [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: 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565499

Locations
Spain
Corporación Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Hospital Universitario de Canarias
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital Insular Materno Infantil de Las Palmas
Las Palmas de Gran Canaria, Spain, 35016
Hospital La Paz
Madrid, Spain, 28046
Hospital Universitario Puerta de Hierro
Madrid, Spain, 28035
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Morales Meseguer
Murcia, Spain, 30008
Instituto Oncológico de Guipúzcoa
San Sebastián, Spain, 20012
Hospital Virgen de la Salud
Toledo, Spain, 45004
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Celgene Corporation
Investigators
Study Director: Miguel Martín, PhD., MD. Hospital General Universitario Gregorio Marañón
  More Information

Additional Information:
No publications provided

Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT01565499     History of Changes
Other Study ID Numbers: GEICAM/2011-02
Study First Received: March 22, 2012
Last Updated: June 7, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Neoadjuvant nab-paclitaxel luminal breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014