Breast CancerPhase 2NCT00251329
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery
A Phase 2 study testing neoadjuvant chemotherapy in people with Breast Cancer, run by Cancer Research Network at 6 sites in United States.
Trial summary
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- neoadjuvant chemotherapy
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2003to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men > 18 years old with histologically confirmed, by needle core biopsy (not FNA), locally advanced or inflammatory breast cancer.
- All patients must have either T2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a T3 N0-N2; T4 any N; or any T with N2 or N3 clinical evidence of disease. Stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. Patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. Patients must have measurable disease defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
- Pre-and Post-menopausal female and male patients are eligible. Women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
- Life expectancy of greater than 6 months.
- Bone scan and CAT scan of chest and abdomen negative for metastatic disease
Who cannot join
- Patients with metastatic disease.
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (NYHA > Class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
- Women who are breast-feeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Baptist Cancer Institute
Jacksonville, Florida, 32207
Lakeland Regional Cancer Center
Lakeland, Florida, 33805
Sos/Acorn
Memphis, Tennessee, 38120
Mount Sinai Comprehensice Cancer Center
Miami, Florida, 33140
Oncology /Hematology Associates of Florida
Miami, Florida, 33176
Cancer Research Network, Inc.
Plantation, Florida, 33324
About this study
Official title: Phase II Neoadjuvant Trial of Docetaxel (Taxotere), Carboplatin, and Capecitabine (Xeloda) in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
Read the detailed description
Neoadjuvant (primary) chemotherapy is being used more frequently in locally advanced breast cancer in an effort to reduce the size of the primary tumor prior to surgery and to eliminate micrometastatic disease.Through previous studies, it has been shown that patients who receive neoadjuvant therapy demonstrate prolonged disease-free survival when compared to those who did not have a pCR at the time of surgery.
It is proven that docetaxel is the single most active drug in metastatic breast cancer treatment and therefore has sparked interest in its use in the neoadjuvant setting. There have been studies conducted using docetaxel either alone or in combination in this setting and in one particular study showed that patients treated with docetaxel after an anthracycline -containing regimen achieved at 34% pCR compared to only 16% with the anthracycline-containing regimen alone. This drugs low incidence of neutropenia when administered on a weekly schedule, plus its possible synergistic effects with carboplatin and capecitabine lead to its inclusion in this neoadjuvant protocol.
Carboplatin is an agent that has recently been integrated into the front line of breast cancer treatment due to its response rate and tolerability. This drug as well has warranted further investigation in the neoadjuvant setting and was combined with docetaxel in one trial for for locally advanced disease which showed a preliminary pCR of the breast and axilla of 30% and 80% respectively. Due to its tolerability, minimal toxicities, and impressive results as a single agent and in combination with docetaxel made carboplatin a reasonable drug of choice in this study.
The novel oral agent capecitabine is being used in this protocol because it has shown through study to significantly increase response rate, time to progression, and even overall survival when combined with docetaxel in the metastatic setting. As well, capecitabine behaves similarly to continuous 5-FU infusion which has shown success in several phase II neoadjuvant trials and essentially has led to its inclusion in this study. Capecitabine's anti-tumor activity, coupled with ease of administration, potential synergism with docetaxel and carboplatin, and non-overlapping toxicities justifies its inclusion in this investigational regimen.
- Conditions
- Breast Cancer
- Being tested
- neoadjuvant chemotherapy
- Keywords
- Neoadjuvant, Breast Cancer, pCR, Capecitabine, Carboplatin, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant chemotherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to establish the pathological complete response rate (pCR) in the breast. The pCR is defined as the absence of invasive carcinoma.
Secondary outcomes (7)
Establish pCR in breast and axillary lymph nodes
Establish pCR in axillary lymph nodes
Objective clinical response rate
Tolerability
Rate of breast conserving surgery
Time to disease progression
Local control rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startMay 2003
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)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Sandra X Franco, MD, Principal investigator, Cancer Research Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251329
- Sponsor's protocol ID
- CRN-004
- Status last verified
- Apr 2007
- First submitted
- 8 Nov 2005
- Last updated
- 4 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Neoadjuvant Trial of Docetaxel (Taxotere), Carboplatin, and Capecitabine (Xeloda) in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer
- ClinicalTrials.gov ID
- NCT00251329
- Acronym / sponsor ID
- CRN-004
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant, Breast Cancer, pCR, Capecitabine, Carboplatin, Docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants
- Lead sponsor
- Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- May 2003
- First posted
- 10 Nov 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.
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
Detailed description
Neoadjuvant (primary) chemotherapy is being used more frequently in locally advanced breast cancer in an effort to reduce the size of the primary tumor prior to surgery and to eliminate micrometastatic disease.Through previous studies, it has been shown that patients who receive neoadjuvant therapy demonstrate prolonged disease-free survival when compared to those who did not have a pCR at the time of surgery.
It is proven that docetaxel is the single most active drug in metastatic breast cancer treatment and therefore has sparked interest in its use in the neoadjuvant setting. There have been studies conducted using docetaxel either alone or in combination in this setting and in one particular study showed that patients treated with docetaxel after an anthracycline -containing regimen achieved at 34% pCR compared to only 16% with the anthracycline-containing regimen alone. This drugs low incidence of neutropenia when administered on a weekly schedule, plus its possible synergistic effects with carboplatin and capecitabine lead to its inclusion in this neoadjuvant protocol.
Carboplatin is an agent that has recently been integrated into the front line of breast cancer treatment due to its response rate and tolerability. This drug as well has warranted further investigation in the neoadjuvant setting and was combined with docetaxel in one trial for for locally advanced disease which showed a preliminary pCR of the breast and axilla of 30% and 80% respectively. Due to its tolerability, minimal toxicities, and impressive results as a single agent and in combination with docetaxel made carboplatin a reasonable drug of choice in this study.
The novel oral agent capecitabine is being used in this protocol because it has shown through study to significantly increase response rate, time to progression, and even overall survival when combined with docetaxel in the metastatic setting. As well, capecitabine behaves similarly to continuous 5-FU infusion which has shown success in several phase II neoadjuvant trials and essentially has led to its inclusion in this study. Capecitabine's anti-tumor activity, coupled with ease of administration, potential synergism with docetaxel and carboplatin, and non-overlapping toxicities justifies its inclusion in this investigational regimen.
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
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women or men > 18 years old with histologically confirmed, by needle core biopsy (not FNA), locally advanced or inflammatory breast cancer.
- All patients must have either T2 lesion which is felt to be initially resectable only through mastectomy by the surgeon, or with a T3 N0-N2; T4 any N; or any T with N2 or N3 clinical evidence of disease. Stage 2 patients where breast conservation surgery is desired but impractical at diagnosis because of anticipated poor cosmetic outcome are eligible. Patients with inflammatory breast carcinoma and women with ipsilateral supraclavicular node involvement are eligible. Patients must have measurable disease defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes and/or ipsilateral internal mammary nodes.
- Pre-and Post-menopausal female and male patients are eligible. Women of childbearing potential must have a negative pregnancy test and, men and women must be willing to consent to using effective dual methods of contraception while on treatment and for three months thereafter.
- Life expectancy of greater than 6 months.
- Bone scan and CAT scan of chest and abdomen negative for metastatic disease
Key exclusion criteria (5 listed)
- Patients with metastatic disease.
- Patients may not be receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection other than mild resolving cellulitis, symptomatic congestive heart failure (NYHA > Class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known coronary artery disease, or psychiatric illness/social situations that would limit compliance with study requirements.
- Cancer other than breast primary within the last 5 years with the exception of surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.
- Women who are breast-feeding.
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 |
|---|---|---|
| neoadjuvant chemotherapy | Drug | – |
Primary outcome
The primary objective of this study is to establish the pathological complete response rate (pCR) in the breast. The pCR is defined as the absence of invasive carcinoma.
7 secondary outcomes
Establish pCR in breast and axillary lymph nodes
Establish pCR in axillary lymph nodes
Objective clinical response rate
Tolerability
Rate of breast conserving surgery
Time to disease progression
Local control rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2007.
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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.
Sandra X Franco, MD principal investigator
Cancer Research Network, Inc.
6 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 neoadjuvant chemotherapy in people with Breast Cancer, run by Cancer Research Network at 6 sites in United States.
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 5 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: status not confirmed, as of the sponsor's last update on 4 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
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?
The primary objective of this study is to establish the pathological complete response rate (pCR) in the breast. The pCR is defined as the absence of invasive carcinoma.. 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 4 Apr 2007.