Stages II-III Breast CancerPhase 1NACNCT01090128
Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
A Phase 1 study testing Nanoparticle Albumin Bound Paclitaxel, doxorubicin and cyclophosphamide in people with Stages II-III Breast Cancer, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stages II-III Breast Cancer
- What is being tested?
- Nanoparticle Albumin Bound Paclitaxel, doxorubicin and cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to 24 Mar 2017
- Phase
- Phase 1
- 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
Who may be able to join
- Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 7th Edition, 2009
- The following receptor status:
- Expansion: Triple negative (ER<1%, PR<1%, and Her-2/neu negative Phase 1 (closed): Negative Her-2/neu status
- ECOG performance status 0 or 1
- Negative pregnancy test
- Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram
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- ANC greater than or equal to 1,500/mm3; platelet greater than or equal to 100,000/mm3; hemoglobin greater than or equal to 9 gm/dL
- Serum bilirubin levels less than or equal to 1.5 mg/dL
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 X upper limit of normal, alkaline phosphatase less than or equal to 2.5 X upper limit of normal.
- Serum creatinine levels less than or equal to 1.5 mg/dL
- Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with nab-paclitaxel through 28 days after the last dose. Men should be advised to not father a child while receiving treatment with azacitidine or nab-paclitaxel. Appropriate methods of birth controls for women include oral or implanted contraceptives, intrauterine device (IUD), diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner and also based on the judgment of the investigator.
- Female, greater than or equal to 19 years of age and any race.
Who cannot join
- Concurrent therapy with any other non-protocol anti-cancer therapy
- For Phase I patients only: Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
- Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline
- History of any other malignancy requiring active treatment
- Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- Currently active infection.
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- History of HIV infection or chronic hepatitis B or C.
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
- Pregnancy or breast feeding
- A history of a severe hypersensitivity reaction to nab-paclitaxel.
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.
Read the detailed description
This is a single center, open phase I dose escalation study with expansion cohort. The dose escalation part of the study is now closed and the highest tolerable dose of nab-paclitaxel (Abraxane) was assessed to be 100 mg/m2 in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The initial phase I study objective was to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. 25 patients were enrolled. The expansion cohort will enroll 15 additional patients.
The purpose of the expansion cohort is to assess pathological complete response.
- Conditions
- Stages II-III Breast Cancer
- Being tested
- Nanoparticle Albumin Bound Paclitaxel, doxorubicin, cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoparticle Albumin Bound PaclitaxelDrug
Also called Abraxane
IV administered over 30 minutes. 100 mg/m2 on days 1 and 8
doxorubicinDrug
Also called Adriamycin
50 mg/m2 every 3 weeks
cyclophosphamideDrug
500 mg/m2 given every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled. Receives: Drug: Nanoparticle Albumin Bound Paclitaxel; Drug: doxorubicin; Drug: cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Measured: one year
Pathologic complete response
Measured: 1 year
Secondary outcomes (1)
Overall clinical response rate (OcRR)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startSep 2008
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
Why it stopped: Drug Manufacturer withdrew support for studies not in metastatic breast cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stages II-III Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Hung Khong, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090128
- Sponsor's protocol ID
- HCI53989
- Acronym
- NAC
- Status last verified
- Mar 2017
- First submitted
- 17 Mar 2010
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
- ClinicalTrials.gov ID
- NCT01090128
- Acronym / sponsor ID
- NAC / HCI53989
- Conditions
- Stages II-III Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drug Manufacturer withdrew support for studies not in metastatic breast cancer
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Sep 2008
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 19 Mar 2010 (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 clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.
Detailed description
This is a single center, open phase I dose escalation study with expansion cohort. The dose escalation part of the study is now closed and the highest tolerable dose of nab-paclitaxel (Abraxane) was assessed to be 100 mg/m2 in combination with doxorubicin (Adriamycin) and cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting. The initial phase I study objective was to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination. 25 patients were enrolled. The expansion cohort will enroll 15 additional patients.
The purpose of the expansion cohort is to assess pathological complete response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: Nanoparticle Albumin Bound Paclitaxel, Drug: doxorubicin, Drug: cyclophosphamideAll participants enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically proven adenocarcinoma of the breast stages II-III, according to the AJCC Staging Manual, 7th Edition, 2009
- The following receptor status:
- Expansion: Triple negative (ER<1%, PR<1%, and Her-2/neu negative Phase 1 (closed): Negative Her-2/neu status
- ECOG performance status 0 or 1
- Negative pregnancy test
Key exclusion criteria (11 listed)
- Concurrent therapy with any other non-protocol anti-cancer therapy
- For Phase I patients only: Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators
- Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline
- History of any other malignancy requiring active treatment
- Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
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 |
|---|---|---|
| Nanoparticle Albumin Bound PaclitaxelAlso: AbraxaneIV administered over 30 minutes. 100 mg/m2 on days 1 and 8 | Drug | All patients |
| doxorubicinAlso: Adriamycin50 mg/m2 every 3 weeks | Drug | All patients |
| cyclophosphamide500 mg/m2 given every 3 weeks | Drug | All patients |
Primary outcome
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities
Time frame: one year
Pathologic complete response
Time frame: 1 year
1 secondary outcome
Overall clinical response rate (OcRR)
Time frame: one year
Results and safety
The study was stopped early (reason given: Drug Manufacturer withdrew support for studies not in metastatic breast cancer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Hung Khong, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nanoparticle Albumin Bound Paclitaxel, doxorubicin and cyclophosphamide in people with Stages II-III Breast Cancer, run by University of Utah 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 12 inclusion and 11 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 31 Mar 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Drug Manufacturer withdrew support for studies not in metastatic breast cancer). 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?
Type, incidence, severity, timing, seriousness and relatedness of adverse events and laboratory abnormalities (time frame: one year). 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 31 Mar 2017.