Breast CancerPhase 2NCT00524459
Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
A Phase 2 study testing docetaxel, pegylated liposomal doxorubicin hydrochloride and conventional surgery in people with Breast Cancer, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 64 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel, pegylated liposomal doxorubicin hydrochloride and conventional surgery
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 64 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 10 years
- Platelet count ≥ 100,000/mm³
- ANC ≥ 1,500/mm³
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- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- AST or ALT normal
- Alkaline phosphatase normal
- Serum creatinine normal
- Negative pregnancy test
- Fertile patients must use effective contraception (e.g., abstinence, intrauterine device, barrier device with spermicide, or surgical sterilization) during and for 3 months after completion of study therapy
- Normal cardiac function by LVEF or MUGA scan
- Patients with prior non-breast malignancies are eligible if they have been disease-free for ≥ 10 years
- The following are allowed even if diagnosed within the past 10 years:
- Squamous or basal cell carcinoma of the skin that has been effectively treated
- Carcinoma in situ of the cervix that has been treated by operation only
- Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmental resection only
- Concurrent noncancer therapies allowed if used for conditions other than breast cancer
- Adjuvant therapy after surgery allowed
Who cannot join
- Pregnant or lactating women
- Male patients
- Hyperbilirubinemia
- Female patients with 1 or more of the following conditions:
- Ulceration, erythema, infiltration of the skin (complete fixation), or peau d'orange (edema) of any magnitude
- Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration
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- Ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease)
- Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
- Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumor
- Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
- Active cardiac disease that would preclude the use of doxorubicin hydrochloride, including any of the following:
- Documented myocardial infarction
- Angina pectoris that requires the use of antianginal medication
- History of documented New York Heart Association class II-IV heart failure
- Valvular disease with documented cardiac function compromise
- Poorly controlled hypertension (i.e., diastolic BP > 100 mm Hg)
- Patients with well-controlled hypertension and on medication are eligible for study
- Psychiatric or addictive disorders that would preclude obtaining informed consent
- PRIOR CONCURRENT THERAPY:
- Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast cancer
- Prior anthracycline therapy for any condition
- Concurrent hormonal therapy including tamoxifen, aromatase inhibitors, or raloxifene
- Concurrent sex hormonal therapy including birth-control pills or ovarian hormonal replacement therapy
- Concurrent other cancer therapy
- Concurrent herbal or alternative therapies for breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.
Secondary
- To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
- To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
- To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.
OUTLINE: This is a multicenter study.
Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy.
After completion of study therapy, patients are followed periodically for up to 5 years.
- Conditions
- Breast Cancer
- Being tested
- docetaxel, pegylated liposomal doxorubicin hydrochloride, conventional surgery, neoadjuvant therapy
- Keywords
- stage IIIA breast cancer, stage IIIB 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.
docetaxelDrug
pegylated liposomal doxorubicin hydrochlorideDrug
conventional surgeryProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Measured: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Clinical Complete Response
Measured: Surgery done after completion of six cycles of study chemotherapy treatment.
Secondary outcomes (3)
Overall Clinical Local Regional Response
Measured: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy
Measured: Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.
Safety, in Terms of Neutropenia and Cardiac Toxicity
Measured: Every cycle during study treatment and 8 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2008
Why it stopped: Terminated by sponsor due to lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tracey O'Connor, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524459
- Sponsor's protocol ID
- I 75506
- Other IDs
- RPCI-I-75506
- Status last verified
- Aug 2014
- First submitted
- 31 Aug 2007
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00524459
- Acronym / sponsor ID
- I 75506
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated by sponsor due to lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 3 Sep 2007 (estimated)
- Results
- Posted 22 Aug 2014
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 liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
Detailed description
OBJECTIVES:
Primary
- To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.
Secondary
- To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
- To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
- To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.
OUTLINE: This is a multicenter study.
Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy.
After completion of study therapy, patients are followed periodically for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
Who may qualify
- Ages
- Up to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 10 years
- Platelet count ≥ 100,000/mm³
Key exclusion criteria (25 listed)
- Pregnant or lactating women
- Male patients
- Hyperbilirubinemia
- Female patients with 1 or more of the following conditions:
- Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
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 |
|---|---|---|
| docetaxel | Drug | – |
| pegylated liposomal doxorubicin hydrochloride | Drug | – |
| conventional surgery | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Pathological Complete Response
Time frame: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Clinical Complete Response
Time frame: Surgery done after completion of six cycles of study chemotherapy treatment.
3 secondary outcomes
Overall Clinical Local Regional Response
Time frame: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.
Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy
Time frame: Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.
Safety, in Terms of Neutropenia and Cardiac Toxicity
Time frame: Every cycle during study treatment and 8 weeks post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Tracey O'Connor, MD principal investigator
Roswell Park Cancer Institute
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 docetaxel, pegylated liposomal doxorubicin hydrochloride and conventional surgery in people with Breast Cancer, run by Roswell Park Cancer Institute 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?
The sponsor lists 21 inclusion and 25 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: stopped early, as of the sponsor's last update on 29 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pathological Complete Response (time frame: Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.). The study lists 2 primary outcomes in all. 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 29 Aug 2014.