Breast CancerNCT00647218
Paclitaxel and Radiation Therapy in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer
A study testing Post-operative adjuvant therapy, neoadjuvant therapy and therapeutic surgical procedure in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. 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?
- Post-operative adjuvant therapy, neoadjuvant therapy and therapeutic surgical procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2000to Nov 2004
- Phase
- Interventional
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically documented invasive carcinoma of the breast*
- Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g., N0-3), including locally advanced disease, as defined by the following criteria:
- Primary tumor ≥ 5 cm
- Tumor of any size with direct extension to the chest wall or skin
- Inflammatory breast cancer (T4d)
- Metastasis to ipsilateral internal mammary node
- Ipsilateral lymph nodes that are clinically fixed to each other or to other structures (N2) NOTE: *Diagnosis may be made by core or tru-cut biopsies
- Measurable or evaluable tumor
- Measurable disease is defined as any mass that can be reproducibly measured in two perpendicular dimensions
- Evaluable disease is defined as any lesion visible by mammogram or palpable by physical exam that does not fit the above criteria of measurability
- Planning to undergo breast conservation surgery
- Willing to undergo AND is a candidate for radiotherapy, in the judgement of the treating radiation oncologist
- No evidence of distant metastatic disease (e.g., lung, liver, bone, brain)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Left ventricular ejection fraction ≥ 45%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancies within the past 5 years, except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
- No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
- No serious medical illness that, in the judgment of the treating physician, places the patient at risk
- No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
- Prior tamoxifen as chemoprevention allowed
- No prior radiotherapy to the ipsilateral breast
- Prior radiotherapy to the contralateral breast is allowed
- No prior chemotherapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Williamson Medical Center
Frankling, Tennessee, 37067
Jackson-Madison Hospital
Jackson, Tennessee, 38301
Boston Baskin Cancer Center
Memphis, Tennessee, 38104
Methodist Lebonheur Healthcare
Memphis, Tennessee, 38104
Meharry Medical College
Nashville, Tennessee, 37208
Vanderbilt-Ingram Cancer Cetner
Nashville, Tennessee
About this study
Official title: A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation therapy works in treating patients undergoing surgery for stage II or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer.
Secondary
- Evaluate the toxicities of this treatment regimen.
- Correlate paclitaxel-induced tumor response with local recurrence-free survival, distant disease-free survival, and overall survival.
- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood specimens collected before and after treatment with paclitaxel.
OUTLINE:
- Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy, patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once daily, 5 days a week, for 6½ weeks.
- Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection (e.g., modified radical mastectomy or lumpectomy and axillary node dissection).
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the discretion of the treating physician.
Patients undergo blood and tissue sample collection periodically to analyze changes in cell cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays for p53, p21, and other molecular markers; and protein expression assays by mass spectrometry.
After completion of study therapy, patients are followed periodically.
- Conditions
- Breast Cancer
- Being tested
- Post-operative adjuvant therapy, neoadjuvant therapy, therapeutic surgical procedure, Radiation therapy with concurrent Paclitaxel, Hormonal Therapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
Post-operative adjuvant therapyDrug
Also called None noted
Adriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles.
Also called None noted
Paclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles
therapeutic surgical procedureProcedure or surgery
Also called None noted
Modified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy.
Radiation therapy with concurrent PaclitaxelRadiation
Also called None noted
Radiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week
Hormonal TherapyDrug
After completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: Post-operative adjuvant therapy; Drug: neoadjuvant therapy; Procedure: therapeutic surgical procedure; Radiation: Radiation therapy with concurrent Paclitaxel; Drug: Hormonal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
Measured: 9 weeks
Secondary outcomes (3)
Toxicity paclitaxel and radiation
Measured: at 18 weeks
Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival
Measured: at time of disease progression or death by any cause
Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel
Measured: Baseline and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startFeb 2000
- Primary completionNov 2004
- Study completionNov 2004
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- A. Bapsi Chakravarthy, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647218
- Sponsor's protocol ID
- VCC BRE 9936
- Other IDs
- P30CA068485, VU-VICC-BRE-9936
- Status last verified
- Feb 2017
- First submitted
- 28 Mar 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant Paclitaxel and Concurrent Radiation With Correlative Molecular Studies in Stage II/III Breast Cancer
- ClinicalTrials.gov ID
- NCT00647218
- Acronym / sponsor ID
- VCC BRE 9936
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 31 Mar 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 paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This clinical trial is studying how well giving paclitaxel together with radiation therapy works in treating patients undergoing surgery for stage II or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of paclitaxel and concurrent radiotherapy (as measured by pathologic response rates) in patients with stage II or III breast cancer.
Secondary
- Evaluate the toxicities of this treatment regimen.
- Correlate paclitaxel-induced tumor response with local recurrence-free survival, distant disease-free survival, and overall survival.
- Evaluate protein expression profiles by mass spectrometry in biopsy material and blood specimens collected before and after treatment with paclitaxel.
OUTLINE:
- Neoadjuvant chemotherapy: Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
- Chemoradiotherapy: Beginning 3-4 weeks after completion of neoadjuvant chemotherapy, patients receive paclitaxel IV over 1 hour twice weekly and undergo radiotherapy once daily, 5 days a week, for 6½ weeks.
- Surgery: At 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection (e.g., modified radical mastectomy or lumpectomy and axillary node dissection).
- Adjuvant chemotherapy: Beginning 4-6 weeks after surgery, patients receive doxorubicin hydrochloride IV over 20 minutes and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Hormonal therapy: After completion of adjuvant chemotherapy, patients with estrogen receptor- and/or progesterone receptor-positive tumor receive hormonal therapy at the discretion of the treating physician.
Patients undergo blood and tissue sample collection periodically to analyze changes in cell cycle by flow cytometry; antibody assays; kinase assays for cyclin B1/CDC2; genetic assays for p53, p21, and other molecular markers; and protein expression assays by mass spectrometry.
After completion of study therapy, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Post-operative adjuvant therapy, Drug: neoadjuvant therapy, Procedure: therapeutic surgical procedure, Radiation: Radiation therapy with concurrent Paclitaxel, Drug: Hormonal Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| Post-operative adjuvant therapyAlso: None notedAdriamycin 60 mg/m2 IV over 20 minutes and Cytoxan 600 mg/m2 IV over 1 hour will be given every three weeks for 4 cycles. | Drug | Experimental |
| neoadjuvant therapyAlso: None notedPaclitaxel 175 mg/m2 IV every 3 weeks x 3 cycles | Drug | Experimental |
| therapeutic surgical procedureAlso: None notedModified radical mastectomy or segmental mastectomy plus axillary dissection 6-8 weeks following completion of chemotherapy/Radiotherapy. | Procedure or surgery | Experimental |
| Radiation therapy with concurrent PaclitaxelAlso: None notedRadiation to breast 4680 cGy/26 fractions with concurrent Paclitaxel 30 mg/m2, twice per week | Radiation | Experimental |
| Hormonal TherapyAfter completion of postoperative adjuvant Adriamycin and Cytoxan, hormonal therapy should be given at the discretion of the treating physician for all post-menopausal ER and/or PR positive patients. It is also recommended for pre-menopausal patients who are ER and/or PR positive. | Drug | Experimental |
Primary outcome
Pathologic Complete Response Rate
Time frame: 9 weeks
3 secondary outcomes
Toxicity paclitaxel and radiation
Time frame: at 18 weeks
Correlation of tumor response with local recurrence-free survival, distant disease-free survival, and overall survival
Time frame: at time of disease progression or death by any cause
Protein expression profiles as measured by mass spectrometry before and after treatment with paclitaxel
Time frame: Baseline and 18 weeks
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 23 Feb 2017.
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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.
A. Bapsi Chakravarthy, MD study chair
Vanderbilt-Ingram Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative adjuvant therapy, neoadjuvant therapy and therapeutic surgical procedure in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center 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?
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 23 Feb 2017. 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.
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?
Pathologic Complete Response Rate (time frame: 9 weeks). 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 23 Feb 2017.