Breast CancerPhase 2NCT00080626
Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
A Phase 2 study testing pegfilgrastim, docetaxel and conventional surgery in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed. 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?
- pegfilgrastim, docetaxel and conventional surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2003to 1 May 2006
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating carcinoma of the breast
- Unresected clinical stage T1c, T2, T3, or T4 lesion, any N
- Newly diagnosed disease
- Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry
- Mammogram of the contralateral breast within 6 months before study entry
- Clinically measurable disease
- Hormone receptor status:
- Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than 1.5 times normal
Renal
- Creatinine no greater than 1.5 times normal
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for current breast cancer
Endocrine therapy
- At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention
- No prior endocrine therapy for current breast cancer
Radiotherapy
- No prior radiotherapy for current breast cancer
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer.
Secondary
- Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician.
- Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician.
- Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician.
- Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- pegfilgrastim, docetaxel, conventional surgery, neoadjuvant therapy
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV 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.
pegfilgrastimBiological
Also called Neulasta
6 mg injection on day 1 of each cycle
docetaxelDrug
Also called Taxotere
100 mg per meter-squared, every 14 days for 4 cycles
conventional surgeryProcedure or surgery
Also called definitive surgery
lumpectomy or mastectomy at end of treatment
neoadjuvant therapyProcedure or surgery
treatment prior to definitive breast surgery
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Experimental | Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer. Receives: Biological: pegfilgrastim; Drug: docetaxel; Procedure: conventional surgery; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between change in apoptosis and proliferation with response after definitive surgery
Measured: Definitive surgery
Secondary outcomes (1)
Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
Measured: Definitive surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study start11 Aug 2003
- Primary completion1 May 2006
- Study completion1 May 2006
Why it stopped: low accrual
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vered Stearns, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080626
- Sponsor's protocol ID
- J0266
- Other IDs
- P50CA088843, P30CA006973, NA_00040559, JHOC-03012301, JHOC-J0266, CDR0000346460
- Status last verified
- Mar 2019
- First submitted
- 7 Apr 2004
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer
- ClinicalTrials.gov ID
- NCT00080626
- Acronym / sponsor ID
- J0266
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Aug 2003 (actual)
- Primary completion
- 1 May 2006 (actual)
- Study completion
- 1 May 2006 (actual)
- First posted
- 8 Apr 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 docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.
Detailed description
OBJECTIVES:
Primary
- Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer.
Secondary
- Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
- Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
- Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician.
- Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician.
- Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician.
- Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Experimental | Biological: pegfilgrastim, Drug: docetaxel, Procedure: conventional surgery, Procedure: neoadjuvant therapyNeoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer. |
Who may qualify
- Ages
- 18 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 |
|---|---|---|
| pegfilgrastimAlso: Neulasta6 mg injection on day 1 of each cycle | Biological | Docetaxel |
| docetaxelAlso: Taxotere100 mg per meter-squared, every 14 days for 4 cycles | Drug | Docetaxel |
| conventional surgeryAlso: definitive surgerylumpectomy or mastectomy at end of treatment | Procedure or surgery | Docetaxel |
| neoadjuvant therapytreatment prior to definitive breast surgery | Procedure or surgery | Docetaxel |
Primary outcome
Correlation between change in apoptosis and proliferation with response after definitive surgery
Time frame: Definitive surgery
1 secondary outcome
Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
Time frame: Definitive surgery
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
Vered Stearns, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 pegfilgrastim, docetaxel and conventional surgery in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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: stopped early, as of the sponsor's last update on 21 Mar 2019. 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 was stopped early (reason given: low accrual). 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?
Correlation between change in apoptosis and proliferation with response after definitive surgery (time frame: Definitive surgery). 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 21 Mar 2019.