Breast CancerPhase 4OTT15-04NCT02688803

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)

A Phase 4 study testing Dose dense AC-P, Dose dense AC and FEC-D in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Dose dense AC-P, Dose dense AC and FEC-D
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteCanada
Study dates: 30 Aug 2016to Oct 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 8L6

Other trials in Canada

About this study

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

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.

Conditions: Breast Cancer
Being tested: Dose dense AC-P, Dose dense AC, FEC-D
Keywords: HER2 Negative
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dose dense AC-PDrug
Also called doxorubicin, cyclophosphamide, paclitaxel
(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 ACDrug
Also called doxorubicin, cyclophosphamide, paclitaxel
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)
FEC-DDrug
Also called 5-FU, cyclophosphamide, docetaxel
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)

Study groups in NCT02688803
Study group	Role	What they receive
Dose dense AC-P	Active comparator	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) Receives: Drug: Dose dense AC-P
Dose dense AC	Active comparator	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) Receives: Drug: Dose dense AC
FEC-D	Active comparator	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) Receives: Drug: FEC-D

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One year
Participant Satisfaction
Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey
Measured: One year

Secondary outcomes (3)

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.
Measured: One year
Hospitalization
The number of participants with adverse effects requiring hospitalization
Measured: One year
Treatment Delays
The number of participants with adverse effects requiring treatment delays
Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 2016Oct 2017

First posted23 Feb 2016 (estimated)
Study start30 Aug 2016
Primary completionOct 2017
Study completionOct 2017

Why it stopped: The study did not meet the pilot feasibility endpoints and was formally closed to accrual prematurely on February 8, 2017.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688803
Sponsor's protocol ID: 20160078-01H
Acronym: OTT15-04
Status last verified: Nov 2025
First submitted: 18 Feb 2016
Last updated: 4 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Jacobs C, Clemons M, Mazzarello S, Hutton B, Joy AA, Brackstone M, Freedman O, Vandermeer L, Ibrahim M, Fergusson D, Hilton J. Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Support Care Cancer. 2017 Jun;25(6):1881-1886. doi: 10.1007/s00520-017-3580-4. Epub 2017 Jan 27.
PubMed 28127659
Hilton J, Stober C, Mazzarello S, Vandermeer L, Fergusson D, Hutton B, Clemons M. Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial). PLoS One. 2018 Jul 24;13(7):e0199297. doi: 10.1371/journal.pone.0199297. eCollection 2018.
PubMed 30040817

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02688803
Acronym / sponsor ID: OTT15-04 / 20160078-01H
Conditions: Breast Cancer
Keywords: HER2 Negative
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study did not meet the pilot feasibility endpoints and was formally closed to accrual prematurely on February 8, 2017.
Enrolment: 2 participants (actual)
Lead sponsor: Ottawa Hospital Research InstituteUniversity, hospital or other
Study start: 30 Aug 2016 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Oct 2017 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 4 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dose dense AC-P	Active comparator	Drug: Dose dense AC-PDose 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	Active comparator	Drug: Dose dense ACDose 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)
FEC-D	Active comparator	Drug: FEC-DFEC-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)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dose dense AC-PAlso: doxorubicin, cyclophosphamide, paclitaxel(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
Dose dense ACAlso: doxorubicin, cyclophosphamide, paclitaxelDose 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
FEC-DAlso: 5-FU, cyclophosphamide, docetaxelFEC-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

Primary outcome

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.
Participant Satisfaction
Time frame: One year
Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey

3 secondary outcomes

Percentage of Participants Who Complete Study Treatment
Time frame: One year
Hospitalization
Time frame: One year
Treatment Delays
Time frame: One year

Results and safety

Results posted to the registry on 4 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Dense AC-P	1	1
Dose Dense AC	0	0
FEC-D	1	1

Primary outcome: Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC

Time frame: One year. Count of participants. Unit: Participants

Measure	Dose Dense AC-P n = 1	Dose Dense AC n = 0	FEC-D n = 1
Received chemotherapy	1	–	1
Chemotherapy dose adjustments or delays	0	–	1
Completed study as planned	0	–	1

Population analysed: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.

Primary outcome: Participant Satisfaction

Time frame: One year. Count of participants. Unit: Participants

Measure	Dose Dense AC-P n = 1	Dose Dense AC n = 0	FEC-D n = 1
The clinical trial was explained clearly to me by my oncologist.: Strongly disagree	0	–	0
The clinical trial was explained clearly to me by my oncologist.: Disagree	0	–	0
The clinical trial was explained clearly to me by my oncologist.: Neutral	0	–	0
The clinical trial was explained clearly to me by my oncologist.: Agree	1	–	1
The clinical trial was explained clearly to me by my oncologist.: Strongly agree	0	–	0
The clinical trial was explained clearly to me by my oncologist.: Not applicable	0	–	0
I thought that the questions I had about the clinical trial were answered to my satisfaction.: Strongly disagree	0	–	0
I thought that the questions I had about the clinical trial were answered to my satisfaction.: Disagree	0	–	0

Population analysed: No participants were randomized to the Dose-dense AC group.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was followed for approximately one year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Dense AC-P	0 of 0	0 of 0	0 of 1
Dose Dense AC	0 of 0	0 of 0	0
FEC-D	0 of 0	0 of 0	0 of 1

Limitations and caveats (from the sponsor): The study did not meet feasibility and was terminated early. The study only involved 2 cancer centres. Physicians reported few TNBC patients in their clinics, and that it was challenging to tell a TNBC patient that the optimal chemotherapy regimen for their condition is unknown.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28127659Jacobs C, Clemons M, Mazzarello S, Hutton B, Joy AA, Brackstone M, Freedman O, Vandermeer L, Ibrahim M, Fergusson D, Hilton J. Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients. Support Care Cancer. 2017 Jun;25(6):1881-1886. doi: 10.1007/s00520-017-3580-4. Epub 2017 Jan 27.
Results publication: PubMed 30040817Hilton J, Stober C, Mazzarello S, Vandermeer L, Fergusson D, Hutton B, Clemons M. Randomised feasibility trial to compare three standard of care chemotherapy regimens for early stage triple-negative breast cancer (REaCT-TNBC trial). PLoS One. 2018 Jul 24;13(7):e0199297. doi: 10.1371/journal.pone.0199297. eCollection 2018.
The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Hilton, Dr. principal investigator

The Ottawa Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dose dense AC-P, Dose dense AC and FEC-D in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688803, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.