Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 99 for:    FEC

Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) (OTT15-04)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02688803
Recruitment Status : Completed
First Posted : February 23, 2016
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2.

TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. Clinically, patients with TNBC have a poorer prognosis compared to patients diagnosed with other breast cancer subtypes. Because of the aggressive phenotype and due to observations that systemic chemotherapy offers significantly higher benefit in ER negative disease, current treatment guidelines from provincial and other organizations recommend that patients receive adjuvant systemic chemotherapy for any TNBC greater than 0.5 cm in greatest diameter or node positive independent of primary tumor size.

Currently, there is no world-wide standard recommended chemotherapy regimen for the management of TNBC in the neoadjuvant/adjuvant setting, with treatments varying from region and institution.

As physicians do not know what the "best" treatment for patients is, genuine uncertainty ("clinical equipoise") exists. Physicians will choose between different "standards" in their personal practice, using idiosyncratic decision making processes, without the physician or the patient knowing the optimal option. This is not good for patients, physicians and society as a whole. Determining the optimal treatment remains an important medical issue for patients, physicians and society. This study will survey opinions on a novel method to allow comparisons of established standard of care prophylactic treatment using the "integrated consent model" as part of a pragmatic clinical trial and attempt to compare head to head standard chemotherapy regimens in patients with TNBC.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Dose dense AC-P Drug: Dose dense AC Drug: FEC-D Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) OTT 15-04
Study Start Date : August 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Dose dense AC-P
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Drug: Dose dense AC-P
(doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Other Names:
  • doxorubicin
  • cyclophosphamide
  • paclitaxel

Active Comparator: Dose dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Drug: Dose dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Other Names:
  • doxorubicin
  • cyclophosphamide
  • paclitaxel

Active Comparator: FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
Drug: FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
Other Names:
  • 5-FU
  • cyclophosphamide
  • docetaxel




Primary Outcome Measures :
  1. Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC [ Time Frame: One year ]
    Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization.

  2. Participant satisfaction [ Time Frame: One year ]
    Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey


Secondary Outcome Measures :
  1. Percentage of participants who complete study treatment [ Time Frame: One hour ]
    Percentage of participants who complete study treatment compared to the percentage who discontinue their treatment while on study (compliance) will be calculated using the sites chemotherapy treatment records and data from New Patient Registration.

  2. Hospitalization [ Time Frame: One year ]
    Rate of adverse effects requiring hospitalization

  3. Treatment delays [ Time Frame: One year ]
    Rate of adverse effects requiring treatment delays



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary TNBC breast cancer
  • Planned for chemotherapy
  • ≥18 years of age
  • Able to provide verbal consent
  • Willing to complete a survey

Exclusion Criteria:

  • Metastatic disease
  • Contraindication to one or more of the chemotherapy agents being evaluated in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688803


Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K2H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: John Hilton, Dr. The Ottawa Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02688803     History of Changes
Other Study ID Numbers: 20160078-01H
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:
HER2 Negative

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors