Breast CancerPhase 2NCT00096343
Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer
A Phase 2 study testing carboplatin and paclitaxel in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- carboplatin and paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2005
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive ductal carcinoma or invasive lobular carcinoma of the breast meeting the following stage criteria:
- T2, T3, or T4a-c
- N0-2
- M0
- Inflammatory breast cancer (stage IIIB) allowed
- Measurable disease by mammogram or ultrasound
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL
Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.2 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No comorbid medical condition that would preclude study participation
- No comorbid infection that would preclude study participation
- No clinically significant peripheral neuropathy (> grade 1)
- No prior significant allergic reaction to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
- No dementia or altered mental status that would prohibit understanding of informed consent
- No other primary malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic growth factors
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- At least 3 weeks since prior surgery
Other
- No other concurrent anticancer drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
About this study
Official title: A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin.
- Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy.
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
- Conditions
- Breast Cancer
- Being tested
- carboplatin, paclitaxel
- Keywords
- invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel IV followed by Carboplatin IV | Experimental | paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: carboplatin; Drug: paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Measured: baseline to 18 months
Secondary outcomes (2)
Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen
Measured: baseline through 18 months
Determine the tolerability and toxicity of this regimen in these patients.
Measured: baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startOct 2002
- Primary completionMar 2005
- Study completionMar 2005
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.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Lisle Nabell, University of Alabama at Birmingham
- Investigators
- Lisle M. Nabell, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096343
- Sponsor's protocol ID
- CDR0000377728
- Other IDs
- UAB-0137
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2004
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pre-Operative Taxol and Carboplatin in Women With Newly Diagnosed Locally Advanced Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00096343
- Acronym / sponsor ID
- CDR0000377728
- Conditions
- Breast Cancer
- Keywords
- invasive ductal breast carcinoma, invasive lobular breast carcinoma, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, inflammatory breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 9 Nov 2004 (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 paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. Combining paclitaxel with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin works in treating women who are undergoing surgery for newly diagnosed, locally advanced breast cancer.
Detailed description
OBJECTIVES:
- Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin.
- Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients with non-palpable lymph nodes undergo sentinel lymph node biopsy within 4 weeks before beginning neoadjuvant chemotherapy.
All patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo lumpectomy or modified radical mastectomy. Patients with a positive sentinel lymph node biopsy or palpable axillary adenopathy undergo axillary lymph node dissection. All patients undergoing lumpectomy or mastectomy with high-risk disease also undergo radiotherapy.
Patients refusing lumpectomy or mastectomy due to persistence of disease may undergo core needle biopsy.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel IV followed by Carboplatin IV | Experimental | Drug: carboplatin, Drug: paclitaxelpaclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| carboplatin | Drug | Paclitaxel IV followed by Carboplatin IV |
| paclitaxel | Drug | Paclitaxel IV followed by Carboplatin IV |
Primary outcome
Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin
Time frame: baseline to 18 months
2 secondary outcomes
Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen
Time frame: baseline through 18 months
Determine the tolerability and toxicity of this regimen in these patients.
Time frame: baseline to 18 months
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 4 Dec 2018.
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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.
Lisle M. Nabell, MD principal investigator
University of Alabama at Birmingham
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 carboplatin and paclitaxel in people with Breast Cancer, run by University of Alabama at Birmingham at 1 site 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?
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 4 Dec 2018. 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 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?
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?
Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin (time frame: baseline to 18 months). 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 Dec 2018.