Breast CancerPhase 2NCT00491816
Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
A Phase 2 study testing Erlotinib with neoadjuvant chemotherapy in people with Breast Cancer, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Primary Study Objective: To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer. 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?
- Erlotinib with neoadjuvant chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2017
- 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
Who may be able to join
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Patients must be candidates for neoadjuvant treatment (tumor size > 2 cm, T2, T3, T4 and/or clinical N1 or N2)
- Estrogen Receptor negative, Progesterone Receptor negative and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative)
- Performance status of 2 or better
- No prior chemotherapy or endocrine therapy
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- If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months after the last dose of study drug
- Adequate bone marrow function: neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 11 g/dL
- Adequate kidney function: serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance of ≥ 60 mL/min
- Adequate hepatic function: transaminases < 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL
- Patients must have a serum albumin ≥ 3.0 g/dL
- Patients must have a Prothrombin Time, Partial Thromboplastin Time within normal limits
- Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules
- Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies within 30 days
- Patients will have a baseline mammogram, bone scan, CT chest and abdomen
Who cannot join
- Patients with metastatic disease are excluded from study
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications
- Pregnancy or lactation
- Prior use of an Epidermal growth factor receptor inhibitor
- Patients with a history of chronic pulmonary disease are excluded from study
- Patients with inadequate laboratory values (as defined above) are excluded from study
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- Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study
- Patients with active infection are excluded from study
- Patients with concomitant or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are excluded from study
- Patients with emotional limitations are excluded from study
- Patients with inflammatory breast cancer will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer
Primary Study Objective:
To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer.
Read the detailed description
Twenty percent of women with breast cancer have triple negative breast cancer. The standard treatment for triple negative breast cancer is typically a combination of chemotherapy, surgery, +/- radiation therapy. When treated with standard therapy women with triple negative breast cancer have a worse long term outcomes as compared to women who do not have triple negative breast cancer. Triple negative breast cancer cells usually have a surface marker called EGFR (epidermal growth factor receptor). Women whose breast cancer cells have the EGFR surface marker have worse long term outcomes as compared to women whose tumors do not have the EGFR marker. Erlotinib (Tarceva) targets EGFR and is currently used for treatment of other cancers like lung and pancreas. This study will assess a combination of chemotherapy with erlotinib in women with triple negative breast cancer.
For breast cancer patients who receive chemotherapy first and then get surgery, long-term survival is longer for women who do not have any microscopic cancer at the time of surgery. The primary objective of this study is to assess whether a combination of chemotherapy and erlotinib will result in no evidence of microscopic disease (pCR) at the time of surgery in greater than 20% of enrolled subjects. After completing all chemotherapy, patients will also receive maintenance erlotinib for 12 months. This is given to study the tolerability of maintenance Erlotinib and also to evaluate if maintenance erlotinib will decrease the rate of tumor recurrence.
- Conditions
- Breast Cancer
- Being tested
- Erlotinib with neoadjuvant chemotherapy
- Keywords
- breast, cancer, breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib with neoadjuvant chemotherapyDrug
Also called Tarceva
150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| erlotinib with neoadjuvant chemotherapy | Experimental | Study drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year. Receives: Drug: Erlotinib with neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Measured: After 18 weeks of neoadjuvant therapy
Secondary outcomes (4)
Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy
Measured: After 2 cycles (6 weeks) of therapy
Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib
Measured: After 2 cycles (6 weeks) of therapy
Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib
Measured: During neoadjuvant chemotherapy
Assessment of tolerability of 12 months of maintenance erlotinib treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2014
- Study completionDec 2017 (estimated)
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 Kansas Medical CenterThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Priyanka Sharma, M.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491816
- Sponsor's protocol ID
- 10864
- Status last verified
- Jan 2017
- First submitted
- 22 Jun 2007
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT00491816
- Acronym / sponsor ID
- 10864
- Conditions
- Breast Cancer
- Keywords
- breast, cancer, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Jun 2007 (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.
Primary Study Objective:
To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative breast cancer.
Detailed description
Twenty percent of women with breast cancer have triple negative breast cancer. The standard treatment for triple negative breast cancer is typically a combination of chemotherapy, surgery, +/- radiation therapy. When treated with standard therapy women with triple negative breast cancer have a worse long term outcomes as compared to women who do not have triple negative breast cancer. Triple negative breast cancer cells usually have a surface marker called EGFR (epidermal growth factor receptor). Women whose breast cancer cells have the EGFR surface marker have worse long term outcomes as compared to women whose tumors do not have the EGFR marker. Erlotinib (Tarceva) targets EGFR and is currently used for treatment of other cancers like lung and pancreas. This study will assess a combination of chemotherapy with erlotinib in women with triple negative breast cancer.
For breast cancer patients who receive chemotherapy first and then get surgery, long-term survival is longer for women who do not have any microscopic cancer at the time of surgery. The primary objective of this study is to assess whether a combination of chemotherapy and erlotinib will result in no evidence of microscopic disease (pCR) at the time of surgery in greater than 20% of enrolled subjects. After completing all chemotherapy, patients will also receive maintenance erlotinib for 12 months. This is given to study the tolerability of maintenance Erlotinib and also to evaluate if maintenance erlotinib will decrease the rate of tumor recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erlotinib with neoadjuvant chemotherapy | Experimental | Drug: Erlotinib with neoadjuvant chemotherapyStudy drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patient ≥ 18 years of age
- Histologically proven stage II or III adenocarcinoma of the breast
- Patients must be candidates for neoadjuvant treatment (tumor size > 2 cm, T2, T3, T4 and/or clinical N1 or N2)
- Estrogen Receptor negative, Progesterone Receptor negative and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative)
- Performance status of 2 or better
Key exclusion criteria (11 listed)
- Patients with metastatic disease are excluded from study
- The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications
- Pregnancy or lactation
- Prior use of an Epidermal growth factor receptor inhibitor
- Patients with a history of chronic pulmonary disease are excluded from study
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 |
|---|---|---|
| Erlotinib with neoadjuvant chemotherapyAlso: Tarceva150 mg orally (PO) once daily on days 3 to 14, given with cycle 1 to 6 or 3 to 6 of neoadjuvant chemotherapy | Drug | erlotinib with neoadjuvant chemotherapy |
Primary outcome
Pathological complete response rate (pCR)
Time frame: After 18 weeks of neoadjuvant therapy
4 secondary outcomes
Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy
Time frame: After 2 cycles (6 weeks) of therapy
Estimation of change in ki-67 after 2 cycles of carboplatin/docetaxel based neoadjuvant chemotherapy plus erlotinib
Time frame: After 2 cycles (6 weeks) of therapy
Assessment of toxicity of the combination of carboplatin/docetaxel chemotherapy plus erlotinib
Time frame: During neoadjuvant chemotherapy
Assessment of tolerability of 12 months of maintenance erlotinib treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 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.
Priyanka Sharma, M.D. principal investigator
University of Kansas Medical Center
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 Erlotinib with neoadjuvant chemotherapy in people with Breast Cancer, run by University of Kansas Medical Center 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 15 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: status not confirmed, as of the sponsor's last update on 19 Jan 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 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?
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?
Pathological complete response rate (pCR) (time frame: After 18 weeks of neoadjuvant therapy). 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 19 Jan 2017.