NCT02670109

Brief Summary

Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is approximately 180,000 cases per year. TNBC are known to be more aggressive with poor prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the usage of higher doses of chemotherapy, which results in higher cellular destruction with a decrease of hematological toxicity, it is proposed that this procedure is able to improve prognosis in TNBC patients with no pathologic complete response after neoadjuvant chemotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

2.8 years

First QC Date

January 28, 2016

Last Update Submit

January 10, 2020

Conditions

Triple-Negative Invasive Breast CarcinomaResidual Tumor

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Time from diagnosis to death from any cause.

    One year

Secondary Outcomes (1)

  • Disease Free Survival

    One year

Study Arms (1)

Unique

EXPERIMENTAL

Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.

Drug: CarmustineDrug: CyclophosphamideDrug: CarboplatinProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: Busulfan

Interventions

CarmustineDRUG

300mg/m2, IV, in 3 hours, during day -4

Also known as: BCNU
Unique
CyclophosphamideDRUG

80mg/kg, IV, in 2 hours, during two days -2, -3

Also known as: Cytoxan
Unique
CarboplatinDRUG

1400/m2, IV, in 1 hour, during day -3

Also known as: Paraplatin
Unique
Autologous Hematopoietic Stem Cell TransplantationPROCEDURE

Transfusion, in 3 hours, during day 0

Also known as: Peripheral blood autologous HSCT
Unique
BusulfanDRUG

16mg/kg, Oral, during day -4

Also known as: Myleran
Unique

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Triple Negative Breast Cancer diagnosis (no expression of hormonal receptors or Her2/neu)
  • Previous administration of neoadjuvant chemotherapy (60 days maximum)
  • Residual tumor in the breast and/or lymph nodes
  • Normal renal, liver, heart, lung, and hematopoietic function

You may not qualify if:

  • Pregnancy
  • Disease progression during neoadjuvant therapy
  • Other tumors
  • Non triple negative breast cancer diagnosis
  • Pathological Complete Response achieved

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

CarmustineCyclophosphamideCarboplatinBusulfan

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsCoordination ComplexesButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Eucario Leon Rodriguez, M.D.

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

  • Monica M Rivera Franco, M.D.,MSc

    Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eucario Leon Rodriguez, M.D.

CONTACT

525554870900eucarios@hotmail.com

Monica M Rivera Franco, M.D.,MSc

CONTACT

525554870900monrif_90d@hotmail.com

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

January 28, 2016

First Posted

February 1, 2016

Study Start

February 1, 2018

Primary Completion

November 1, 2020

Study Completion

November 1, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)