Breast CancerPhase 2NCT00801411
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by Surgery
A Phase 2 study testing cyclophosphamide, docetaxel and doxorubicin hydrochloride in people with Breast Cancer, run by National Cancer Centre, Singapore at 2 sites in Singapore.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cyclophosphamide, docetaxel and doxorubicin hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 2 sitesSingapore
- Study dates
- Oct 2008to not given
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Newly diagnosed disease
- Operable disease
- Must have clinical T2 (> 2cm) or T3 (> 5 cm) primary tumors with no clinical lymph node involvement (N0)
- No clinical T4 lesion (e.g., peau d'orange, skin ulceration, satellite nodules, or inflammatory breast cancer)
- No evidence of metastatic disease
- Known hormone receptor status
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy > 10 years
- Leukocytes ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal or creatinine clearance ≥ 40 mL/min
- Normal cardiac ejection fraction, defined as ≥ 50% by MUGA scan or 2D-ECHO
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or other agents used in this study
- No history of pre-existing peripheral neuropathy
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- No prior malignancies except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
- No other concurrent investigational or commercial agents or therapies with the intent to treat the patient's malignancy
- No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, surgery for cancer, or experimental medications
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent antitumor therapy
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Wong Chow Yin, 65-6222-3322
- Recruiting
National Cancer Centre - Singapore
Singapore, 169610
Wong Nan Soon, MBBS, MRCP, FAMS, 65-6-436-8088
About this study
Official title: A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression.
Secondary
- To assess tumor clinical and pathological overall response rates in patients treated with these regimens.
- To assess the safety and toxicity of these regimens.
- To assess disease-free survival and overall survival of these patients.
- To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.
OUTLINE: This is a multicenter study.
Patients are stratified according to hormone receptor status (estrogen receptor [ER]- or progesterone receptor [PR]-positive vs ER- and PR-negative) and T stage (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant chemotherapy, all patients undergo surgery.
Tumor specimens obtained prior to neoadjuvant chemotherapy are analyzed for topoisomerase IIα gene and protein expression by IHC and FISH. Tissue samples are also collected at surgery for future studies.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
- Conditions
- Breast Cancer
- Being tested
- cyclophosphamide, docetaxel, doxorubicin hydrochloride
- Keywords
- stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Given IV
docetaxelDrug
Given IV
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1. Receives: Drug: cyclophosphamide; Drug: docetaxel |
| Arm II | Active comparator | Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Receives: Drug: cyclophosphamide; Drug: doxorubicin hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Secondary outcomes (4)
Clinical and pathological overall response rate
Toxicity as assessed by NCI CTCAE v3.0
Overall survival
Disease-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startOct 2008
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
- Randomised
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Wong Nan Soon, MBBS, MRCP, FAMS, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801411
- Sponsor's protocol ID
- CDR0000624374
- Other IDs
- SINGAPORE-NCC0705, SANOFI-AVENTIS-NCC0705
- Status last verified
- Jun 2009
- First submitted
- 2 Dec 2008
- Last updated
- 17 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression
- ClinicalTrials.gov ID
- NCT00801411
- Acronym / sponsor ID
- CDR0000624374
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Oct 2008
- First posted
- 3 Dec 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, docetaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which chemotherapy regimen is more effective in treating breast cancer.
PURPOSE: This randomized phase II trial is studying cyclophosphamide given together with docetaxel to see how well it works compared with cyclophosphamide given together with doxorubicin in treating women with newly diagnosed breast cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression.
Secondary
- To assess tumor clinical and pathological overall response rates in patients treated with these regimens.
- To assess the safety and toxicity of these regimens.
- To assess disease-free survival and overall survival of these patients.
- To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.
OUTLINE: This is a multicenter study.
Patients are stratified according to hormone receptor status (estrogen receptor [ER]- or progesterone receptor [PR]-positive vs ER- and PR-negative) and T stage (T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1.
- Arm II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1.
In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant chemotherapy, all patients undergo surgery.
Tumor specimens obtained prior to neoadjuvant chemotherapy are analyzed for topoisomerase IIα gene and protein expression by IHC and FISH. Tissue samples are also collected at surgery for future studies.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: cyclophosphamide, Drug: docetaxelPatients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1. |
| Arm II | Active comparator | Drug: cyclophosphamide, Drug: doxorubicin hydrochloridePatients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cyclophosphamideGiven IV | Drug | Arm I, Arm II |
| docetaxelGiven IV | Drug | Arm I |
| doxorubicin hydrochlorideGiven IV | Drug | Arm II |
Primary outcome
Pathological complete response rate
4 secondary outcomes
Clinical and pathological overall response rate
Toxicity as assessed by NCI CTCAE v3.0
Overall survival
Disease-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2009.
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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.
Wong Nan Soon, MBBS, MRCP, FAMS principal investigator
National Cancer Centre, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cyclophosphamide, docetaxel and doxorubicin hydrochloride in people with Breast Cancer, run by National Cancer Centre, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 17 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate. It is what the study was designed to measure, not a finding.
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 17 Jun 2009.