Breast Cancer
Conditions
Keywords
HER2 Negative
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.
Interventions
DRUGDose 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)
DRUGDose 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)
DRUGFEC-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)
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | 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. |
| Participant Satisfaction | One year | Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Complete Study Treatment | One year | 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. |
| Hospitalization | One year | The number of participants with adverse effects requiring hospitalization |
| Treatment Delays | One year | The number of participants with adverse effects requiring treatment delays |
Countries
Canada
Participant flow
Recruitment details
2 patients were approached for the study between August 30, 2016 and January 31, 2017, and both were enrolled and randomized. The study was closed to accrual prematurely on February 8, 2017, because it did not meet the pilot feasibility endpoints. According to the protocol, feasibility success is defined as over 50% of appropriate patients approached agree to participate, and over 50% of physicians who agree to participate approached patients for the study.
Participants by arm
| Arm | Count |
|---|---|
| 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)
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) | 1 |
| 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)
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) | 0 |
| 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)
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) | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | — | Total | Dose Dense AC-P | FEC-D |
|---|---|---|---|---|
| Age, Continuous | — years | — | — | — |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Region of Enrollment Canada | — | 2 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | — | 0 Participants | — | — |
| Sex: Female, Male Male | — | 0 Participants | — | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Participant Satisfaction
Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey
Time frame: One year
Population: No participants were randomized to the Dose-dense AC group.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Agree | 1 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Neutral | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Strongly agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Not applicable | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Agree | 1 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Strongly disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Not applicable | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Disagree | 1 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Strongly agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Neutral | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Agree | 1 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Not applicable | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Strongly agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Strongly disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Not applicable | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Strongly disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Strongly disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Neutral | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Disagree | 1 Participants |
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Neutral | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Disagree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Neutral | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Strongly agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Strongly agree | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Not applicable | 0 Participants |
| Dose Dense AC-P | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Not applicable | 0 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Disagree | 0 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Neutral | 0 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Agree | 1 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Strongly agree | 0 Participants |
| FEC-D | Participant Satisfaction | The clinical trial was explained clearly to me by my oncologist. | Not applicable | 0 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Disagree | 0 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Neutral | 0 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Agree | 1 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Strongly agree | 0 Participants |
| FEC-D | Participant Satisfaction | I thought that the questions I had about the clinical trial were answered to my satisfaction. | Not applicable | 0 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Disagree | 0 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Neutral | 0 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Agree | 1 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Strongly agree | 0 Participants |
| FEC-D | Participant Satisfaction | If I was asked to participate in this study again, I would say yes. | Not applicable | 0 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Disagree | 1 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Neutral | 0 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Agree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Strongly agree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that taking part in this study interfered with my quality of life. | Not applicable | 0 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Strongly disagree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Disagree | 1 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Neutral | 0 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Agree | 0 Participants |
| FEC-D | Participant Satisfaction | I found that it was time-consuming to take part in this study. | Strongly agree | 0 Participants |
Primary
Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC
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.
Time frame: One year
Population: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dose Dense AC-P | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Received chemotherapy | 1 Participants |
| Dose Dense AC-P | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Chemotherapy dose adjustments or delays | 0 Participants |
| Dose Dense AC-P | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Completed study as planned | 0 Participants |
| FEC-D | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Received chemotherapy | 1 Participants |
| FEC-D | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Chemotherapy dose adjustments or delays | 1 Participants |
| FEC-D | Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC | Completed study as planned | 1 Participants |
Secondary
Hospitalization
The number of participants with adverse effects requiring hospitalization
Time frame: One year
Population: There were no participants randomized to the Dose Dense AC group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Dense AC-P | Hospitalization | 0 Participants |
| FEC-D | Hospitalization | 0 Participants |
Secondary
Percentage of Participants Who Complete Study Treatment
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.
Time frame: One year
Population: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Dense AC-P | Percentage of Participants Who Complete Study Treatment | 0 Participants |
| Dose Dense AC | Percentage of Participants Who Complete Study Treatment | 0 Participants |
| FEC-D | Percentage of Participants Who Complete Study Treatment | 1 Participants |
Secondary
Treatment Delays
The number of participants with adverse effects requiring treatment delays
Time frame: One year
Population: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dose Dense AC-P | Treatment Delays | 0 Participants |
| Dose Dense AC | Treatment Delays | 0 Participants |
| FEC-D | Treatment Delays | 1 Participants |