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Triple Negative Breast Cancer PatientsPhase 2CAPneoNCT03304756

Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer With CAP Regimen

A Phase 2 study testing CAP in people with Triple Negative Breast Cancer Patients, run by Instituto Nacional de Cancer, Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer Patients
What is being tested?
CAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
No sites listed yet
Study dates
15 Dec 2007to 15 Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Female patients with locally advanced breast cancer (stages IIB, IIIA and IIIB), confirmed anatomopathologically, with hormonal receptors (Estrogen and / or progesterone) and ERBB2 negative to the immunohistochemical study pattern.
  • Presence of measurable disease according to RECIST criteria.
  • Staging with chest X-ray, abdominal ultrasound and bone scintigraphy Without evidence of metastatic disease. Capture in bone scintigraphy should be Evaluated by simple radiographs.
  • Performance Status (PS) of Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Adequate haematological function, evidenced by higher hemoglobin level Than 9 g / dl, neutrophil count greater than 1,500 / mm 3 and platelet count greater than 100,000 / mm 3.
  • Adequate liver function, evidenced by bilirubin levels below 1.5 of normal values and liver enzyme levels less than 2.5 times normal.
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  • Adequate renal function, evidenced by creatinine levels lower than 1.5 times normal value and / or estimated creatinine clearance (Cockroft) greater than 50 ml / min.
  • Preserved cardiac function assessed by Doppler echocardiography.
  • Socio-cultural ability to understand a clinical study and the need to Attend regularly for medical examinations and appointments.

Who cannot join

  • Patients with a history of previous neoplasia, except non melanoma skin cancer.
  • Previously treatment of breast cancer with surgery, chemotherapy or Hormone therapy.
  • Presence of metastatic disease
  • Concomitant malignant neoplasm (including contralateral breast).
  • Presence of uncontrolled heart, kidney or lung disease.
  • Presence of uncontrolled diabetes mellitus.
  • Pregnancy

About this study

Official title: Phase II Study of Neoadjuvant Treatment of Locally Advanced Breast Cancer Patients With the CAP Regimen

This is a single arm, single center, non-randomized, phase II trial of stage IIB/III TNBC. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles. After surgery, adjuvant chemotherapy consisting of docetaxel (75 mg/m2) every 21 days was further provided for 4 cycles. Primary outcome was pathological complete response in the breast and axilla (pCR; ypT0ypN0). Secondary outcomes were safety, disease-free survival and overall survival.

Read the detailed description

This is a non-randomized, open-label, single arm, single center, phase II clinical trial. Patients received neoadjuvant chemotherapy with cisplatin (50 mg/m2, intravenous [IV], day 1) in combination with doxorubicin (50 mg/m2, IV, day 1) and cyclophosphamide (500 mg/m2, IV, day 1) every 21 days and for a total of 6 cycles (CAP regimen). Subsequent mastectomy plus axillary lymph node dissection was performed. Pathological specimen was analyzed to assess tumor response in the breast and axilla. Adjuvant chemotherapy consisting of docetaxel (75 mg/m2, IV) every 21 days was further provided for 4 cycles. In case of tumor progression during neoadjuvant treatment, CAP was discontinued and additional local or systemic treatment was provided at the discretion of the investigator. The protocol was approved by the institutional review board of National Cancer Institute - Brazil. All patients provided written informed consent. The Brazilian Group of Breast Cancer Studies (GBECAM) and National Cancer Institute -Brazil were the academic sponsors and National Cancer Institute- Brazil was the funding source of the trial.

Being tested
CAP
Keywords
locally advanced breast cancer, triple negative, cisplatin

What participants receive

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

  • CAPDrug

    cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles

Study groups in NCT03304756
Study groupRoleWhat they receive
CAPExperimentalCisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles
Receives: Drug: CAP

What is being measured

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

  1. Pathological complete response (pCR)

    Pathological complete response (pCR) assessed by the local pathology lab, and defined as the absence of tumor (invasive and/or in situ) both in the breast and axilla (ypT0 ypN0)

    Measured: 6 months

Secondary outcomes (3)

  1. Safety assessed according to NCI CTCAE

    Safety was assessed according to NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0.

    Measured: 5 years follow-up

  2. Disease-free survival (DFS)

    DFS was defined as time from surgery to disease recurrence or death from any cause

    Measured: 5 years follow-up

  3. Overall survival (OS)

    OS was defined as time from surgery to death from any cause.

    Measured: 5 years follow-up

Timeline

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

  1. First posted9 Oct 2017
  2. Study start15 Dec 2007
  3. Primary completion15 Apr 2012
  4. Study completion15 Dec 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03304756
Sponsor's protocol ID
Prot 82-07
Acronym
CAPneo
Status last verified
Oct 2017
First submitted
11 Aug 2017
Last updated
25 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data from this study was monitored by the GBECAM (Brazilian Group of studies on breast cancer) and the protocol approved by the research ethics committee of the National Cancer Institute. The collected data are archived in the research center, available for consultation in individual clinical records by patients, in addition to the source documents and folders with all regulatory material of the study. We are in the process of finalizing a scientific paper, to be published in an international magazine, in order to disseminate the results of the study.

Publications

  • Ferreira AR, Metzger-Filho O, Sarmento RMB, Bines J. Neoadjuvant Treatment of Stage IIB/III Triple Negative Breast Cancer with Cyclophosphamide, Doxorubicin, and Cisplatin (CAP Regimen): A Single Arm, Single Center Phase II Study (GBECAM 2008/02). Front Oncol. 2018 Jan 24;7:329. doi: 10.3389/fonc.2017.00329. eCollection 2017.

    PubMed 29416986

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CAP in people with Triple Negative Breast Cancer Patients, run by Instituto Nacional de Cancer, Brazil.

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 9 inclusion and 7 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: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pathological complete response (pCR) (time frame: 6 months). 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 NCT03304756, which also lists 1 linked publication.

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 25 Oct 2017.

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