NCT01565499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2012

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

April 17, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2018

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2020

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

March 22, 2012

Results QC Date

October 1, 2020

Last Update Submit

March 3, 2023

Conditions

Breast Cancer

Keywords

Neoadjuvant nab-paclitaxel luminal breast cancer

Outcome Measures

Primary Outcomes (1)

  • The Residual Cancer Burden Grade III (RCB-III).

    The RCB-III was reported, including a 95% confidence interval. The estimate of the RCB-III was calculated as follows: Overall Response Rate = Number of patients with RCB-III / Intent to treat (ITT) population

    After surgery, up to 4 months

Secondary Outcomes (10)

  • Pathologic Complete Response (pCR) Rate

    After surgery, up to 4 months

  • Objective Response Rate (ORR) by Magnetic Resonance Imaging (MRI)

    After surgery, up to 4 months

  • Objective Response Rate (ORR) by Mammogram

    After surgery, up to 4 months

  • Invasive Disease Free Survival (IDFS)

    Up to 6 years

  • Rate of Conversion to Breast Conserving Surgery (BCS)

    After surgery, up to 4 months

  • +5 more secondary outcomes

Study Arms (1)

Nab-Paclitaxel

EXPERIMENTAL

The patients will be included to receive 3 weekly nab-paclitaxel doses of 150 mg/m2 with one week of rest for 4 cycles.

Drug: Nab-paclitaxel

Interventions

Nab-paclitaxelDRUG
Also known as: Abraxane
Nab-Paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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).
  • Are clear candidates to receive chemotherapy by the investigator criteria.
  • Are at least 18 years of age.
  • Have at least one unidimensionally measurable lesion by RECIST \[65\] version 1.1, measured by mammogram.
  • Have adequate performance status: Eastern Cooperative Oncology Group (ECOG) \<2
  • 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.
  • Exhibit patient compliance and geographic proximity that allow for adequate follow-up
  • Entry informed consent form signed by the patient.

You may not qualify if:

  • Inflammatory breast cancer (T4d) and supraclavicular lymph nodes (N3)
  • Synchronous contralateral or multicentric breast cancer.
  • 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.
  • 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.
  • Prior or concurrent anti-cancer therapy for current disease (hormone therapy, chemotherapy, radiotherapy, immunotherapy, biological therapy other than the trial therapies).
  • Concurrent treatment with any hormonal treatment either for osteoporosis or as replacement therapy.
  • Patients with known hypersensitivity to nab-paclitaxel or any of its components.
  • Previous neuropathy grade \>1 according to the NCI-CTCAE vs 4.03 criteria
  • 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.
  • Have any serious concomitant systemic disorder incompatible with the study (at the discretion of investigator).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Corporación Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Instituto Oncológico de Guipúzcoa

Donostia / San Sebastian, Guipúzcoa, 20012, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Clinic i Provincial

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (1)

  • Martin M, Chacon JI, Anton A, Plazaola A, Garcia-Martinez E, Segui MA, Sanchez-Rovira P, Palacios J, Calvo L, Esteban C, Espinosa E, Barnadas A, Batista N, Guerrero A, Munoz M, Romio E, Rodriguez-Martin C, Caballero R, Casas MI, Rojo F, Carrasco E, Antolin S. Neoadjuvant Therapy with Weekly Nanoparticle Albumin-Bound Paclitaxel for Luminal Early Breast Cancer Patients: Results from the NABRAX Study (GEICAM/2011-02), a Multicenter, Non-Randomized, Phase II Trial, with a Companion Biomarker Analysis. Oncologist. 2017 Nov;22(11):1301-1308. doi: 10.1634/theoncologist.2017-0052. Epub 2017 Jul 12.

    PMID: 28701571RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelAlbumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Scientific Director / Medical Lead / Project Manager
Organization
Spanish Breast Cancer Research Group
geicam@geicam.org
+34916592870

Study Officials

  • Study Director

    Hospital General Universitario Gregorio Marañón

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 28, 2012

Study Start

April 17, 2012

Primary Completion

June 1, 2014

Study Completion

May 27, 2018

Last Updated

March 30, 2023

Results First Posted

November 18, 2020

Record last verified: 2023-03

Locations

ES(13)