Breast CancerPhase 2NCT00135018
Study on the Neoadjuvant Use of Chemotherapy and Celecoxib Therapy in Patients With Invasive Breast Cancer
A Phase 2 study testing celecoxib and chemotherapy in people with Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site in Hong Kong.
Trial summary
This study will investigate whether cyclooxygenase inhibition with celecoxib will add any benefit to preoperative chemotherapy alone for breast cancer patients. 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?
- celecoxib and chemotherapy
- How many people
- Not given
- Where
- 1 siteHong Kong
- Study dates
- Feb 2006to May 2012
- 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
- The patient must be free of psychiatric or addictive disorders and mentally able to follow prescription instructions and able to give written informed consent. The patient must consent to be in the study and must sign an approved consent form conforming to institutional guidelines.
- The patient must be aged 18 years or older.
- The diagnosis of invasive adenocarcinoma of the breast must be confirmed by core or Tru-cut biopsy and the interval between initial histological diagnosis of breast cancer and registration must not be more than 1 month.
- The primary tumor within the breast must be palpable and measurable on clinical examination and ultrasound, and must be confined to one breast. For patients with clinically negative axillary nodes, the primary tumor size must be between 2 to 7 cm. For patients with clinically positive axillary nodes, any primary tumor size up to 7 cm is acceptable (T2-3, N0, M0 or T1-3, N1, M0).
- ECOG performance status of 0-1 or a corresponding Karnofsky performance status of at least 70.
- Within one month prior to the time of registration, the patient must have had the following: history, physical examination, blood tests, tumor estrogen and progesterone receptor status assessment, chest X-ray, bone scan, abdominal ultrasound, bilateral mammogram, and electrocardiogram (ECG).
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- Hematology parameters: white blood cell (WBC) at least 2500/mm3; neutrophil count at least 2,000/mm3; platelet count at least 100,000/mm3; and hemoglobin at least 10g/dL. Other laboratory parameters: total serum bilirubin not exceeding 2 times institutional upper limit of normal (ULN); AST not exceeding 2 times ULN; ALT not exceeding 2 times ULN; alkaline phosphatase not exceeding 2 times ULN; and serum creatinine not exceeding 2 times ULN. In borderline cases, inclusion into the study is left to the judgment of the principal investigator.
- The patient must have adequate ventricular function with left ventricular ejection fraction (LVEF) not less than 55% by echocardiogram scan.
- Patients with prior non-breast malignancies are eligible if they have been disease free for more than 5 years and if they have not received any chemotherapy, immunotherapy, hormonal therapy or radiation therapy within the last 5 years. Patients with curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix are eligible even if diagnosed within the last 5 years prior to registration.
- Patients receiving any sex hormonal therapy e.g., birth control pills, ovarian hormonal replacement therapy, etc., are eligible if such therapy is discontinued 1 month prior to registration.
Who cannot join
- Male patients
- Patients with distant metastasis, including skin involvement beyond the breast area. Patients with ulceration, erythema and infiltration of the skin (complete fixation), inflammatory breast cancer or peau d'orange (edema) of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration and patients with these conditions are eligible.)
- Patients with ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease).
- Patients with a mass in the opposite breast, which is suspicious for malignancy, unless there is biopsy proof that the mass is not malignant.
- Patients with multiple, bilateral breast cancer or suspicious palpable nodes in the contralateral axilla or patients with palpable supraclavicular or infraclavicular nodes, unless there is biopsy proof that the nodes are not involved with malignancy.
- Postmenopausal patients with both positive estrogen and progesterone receptor status and negative lymph node involvement.
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- Pregnant women or women with suspected pregnancy at the time of registration and lactating women are not eligible for the study.
- Patients with prior history of invasive breast cancer; patients with ipsilateral new cancer/recurrence after treatment of in-situ breast cancer; or patients who have received prior therapy for breast cancer, including chemotherapy, immunotherapy, hormonal therapy or radiation therapy.
- Patients who have received any prior anthracycline or docetaxel therapy for any malignancy.
- Patients with serious cardiac illness or medical conditions including, but not confined to:
- History of documented congestive heart failure (CHF);
- High-risk uncontrolled arrhythmias;
- Angina pectoris requiring antianginal medication;
- Clinically significant valvular heart disease;
- Evidence of transmural infarction on ECG; or
- Poorly controlled hypertension (e.g. systolic > 180mmHg or diastolic greater than 100mmHg).
- Patients with any abnormalities in the ECG, e.g., ventricular hypertrophy, even if they demonstrate adequate ventricular function by echocardiogram.
- Patients with active or chronic documented infection at the time of registration.
- Patients with pre-existing peripheral neuropathy (grade 2 or greater according to National Cancer Institute Adverse Event [NCI AE] v 3.0) and patients under risk of developing peripheral neuropathy, i.e., poorly controlled diabetes mellitus.
- Patients with rheumatic disease and patients under cyclooxygenase-2 inhibitor medication.
- Patients who are hepatitis B and/or hepatitis C carriers.
- Patients with known hypersensitivity or contraindication to any study or pre- medications or products formulated in polysorbate 80.
- Patients judged by the investigator to be unfit to be enrolled into the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study on the Neoadjuvant Use of Chemotherapy and Celecoxib Therapy in Patients With Invasive Breast Cancer
This study will investigate whether cyclooxygenase inhibition with celecoxib will add any benefit to preoperative chemotherapy alone for breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- celecoxib and chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxib and chemotherapyDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startFeb 2006
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Organisation for Oncology and Translational Research
- Sponsor type
- University, hospital or other
- Investigators
- Louis WC Chow, Principal investigator, UNIMED Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135018
- Sponsor's protocol ID
- FEC-DOC-CXB-A3
- Status last verified
- May 2012
- First submitted
- 24 Aug 2005
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on the Neoadjuvant Use of Chemotherapy and Celecoxib Therapy in Patients With Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT00135018
- Acronym / sponsor ID
- FEC-DOC-CXB-A3
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Organisation for Oncology and Translational ResearchUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether cyclooxygenase inhibition with celecoxib will add any benefit to preoperative chemotherapy alone for breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient must be free of psychiatric or addictive disorders and mentally able to follow prescription instructions and able to give written informed consent. The patient must consent to be in the study and must sign an approved consent form conforming to institutional guidelines.
- The patient must be aged 18 years or older.
- The diagnosis of invasive adenocarcinoma of the breast must be confirmed by core or Tru-cut biopsy and the interval between initial histological diagnosis of breast cancer and registration must not be more than 1 month.
- The primary tumor within the breast must be palpable and measurable on clinical examination and ultrasound, and must be confined to one breast. For patients with clinically negative axillary nodes, the primary tumor size must be between 2 to 7 cm. For patients with clinically positive axillary nodes, any primary tumor size up to 7 cm is acceptable (T2-3, N0, M0 or T1-3, N1, M0).
- ECOG performance status of 0-1 or a corresponding Karnofsky performance status of at least 70.
Key exclusion criteria (23 listed)
- Male patients
- Patients with distant metastasis, including skin involvement beyond the breast area. Patients with ulceration, erythema and infiltration of the skin (complete fixation), inflammatory breast cancer or peau d'orange (edema) of any magnitude. (Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration and patients with these conditions are eligible.)
- Patients with ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease).
- Patients with a mass in the opposite breast, which is suspicious for malignancy, unless there is biopsy proof that the mass is not malignant.
- Patients with multiple, bilateral breast cancer or suspicious palpable nodes in the contralateral axilla or patients with palpable supraclavicular or infraclavicular nodes, unless there is biopsy proof that the nodes are not involved with malignancy.
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 |
|---|---|---|
| celecoxib and chemotherapy | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Louis WC Chow principal investigator
UNIMED Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib and chemotherapy in people with Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site in Hong Kong.
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 10 inclusion and 23 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 24 May 2012. 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 Hong Kong. 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 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.
Where can I read the original study information?
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 24 May 2012.