Breast CancerPhase 2NCT01036087
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
A Phase 2 study testing Panitumumab, Nab-paclitaxel and Carboplatin in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. 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?
- Panitumumab, Nab-paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to 9 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.
- Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
- >/= Age 18
- ECOG performance status </= 1
- Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL
- Adequate cardiac function (LVEF >/= 45%)
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- Adequate Renal function: Creatinine (Cr) </= 1.5 mg/dL x ULN, Creatinine clearance (CrCl) >/= 50 mL/min calculated by the Cockcroft-Gault method as follows: Male creatinine clearance = (140 - age) x (weight in Kg) / (serum Cr x 72) Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
- Adequate Hepatic function: Aspartate aminotransferase (AST) </= 2.5 x ULN • Alanine aminotransferase (ALT) </= 2.5 x ULN • Alkaline phosphatase (Alp) </= 2.5 x ULN.Total bilirubin </=1.5 x ULN
- Ability and willingness to sign an informed consent form for this protocol
- If female of childbearing potential (women who are post-menopausal < 1 year, not surgically sterilized, or not abstinent), pregnancy urine test is negative, and agrees to be consistent and correct use of one of the following acceptable methods of birth control: male partner who is sterile prior to the female subject entry into the study and is the sole sexual partner for that female subject; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraception, or barrier methods, including diaphragm or condom with a spermicide.
- Patients who have metastatic disease, if the metastatic sites are amendable for local therapy (i.e. radiation and/or surgery), and are candidates for breast surgery will be eligible,
Who cannot join
- History of radiation or chemotherapy
- HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
- Recurrent breast cancer
- History of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
- History of extensive interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of extensive interstitial lung disease on baseline chest CT scan
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- Patient with other significant medical or psychiatric condition that would make assessment of toxicity or efficacy difficult.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Peripheral neuropathy >= Gr II
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
Read the detailed description
Study Drugs:
Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR).
Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor.
Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow.
5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Study Drug Administration:
On Day 1 of Week 1, you will receive panitumumab through a needle in your vein over 60 minutes.
After Week 1, you will receive a total of 4 cycles of PNC. Each cycle is 4 weeks.
During Cycles 1-3 (Weeks 2-13), you will receive PNC by vein once a week for 3 weeks, followed by a week of rest. You will receive PNC through a needle in your vein. The infusion will take 90 minutes.
During Cycle 4 (Week 14 to 17), you will receive PNC on Day 1 of Weeks 14 and 15. On Day 1 of Week 16, you will receive only carboplatin and nab-paclitaxel.
Starting on Day 1 of Week 18, you will receive FEC through a needle in your vein. The infusion will take 90 minutes. You will receive a total of 4 cycles, each 3 weeks long, over 12 weeks.
Surgery:
After you have completed both PNC and FEC treatments, you will have the standard of care surgery performed. You will be given a separate consent form to read and sign.
During surgery, breast tissue samples will be collected to identify tumors as routine procedure.
Study Visits:
Each week that you receive PNC or FEC therapy, before each dose of chemotherapy, blood (about 1 1/2 tablespoons) will be drawn for routine tests.
Before Week 2, an optional breast core biopsy will be performed to collect tumor samples for biomarker testing
On Week 2, every 4 weeks after that until the end of PNC, and again before FEC, the following tests and procedures will be performed before each dose of chemotherapy.
- You will have a physical exam, including measurement of your vital signs and weight, and breast exam.
- Blood (about 1 1/2 tablespoons) will be drawn for routine tests.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
During Weeks 2 and 9, and before FEC therapy, the study doctor will take pictures of both of your breasts.
Before FEC (after Cycle 4 of PNC) and again before surgery, the following tests and procedures will be performed:
- To check the status of the disease, imaging studies including mammogram, breast MRI, breast ultrasound, and digital photograph will be performed.
- You will have a physical exam, including vital signs, weight, and breast exam
- Blood (about 3 tablespoons) will be drawn for routine tests.
- You will be asked about any symptoms that you may have.
- The ECGs and ECHO/MUGA scans will be repeated, when the doctor thinks it is necessary.
This schedule may be changed if the study doctor thinks that it is necessary.
Length of the study:
You may remain on study treatment for up to 10 months. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. It's use in this study is considered to be investigational.
Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The use of Nab-paclitaxel in this study is considered to be investigational.
Carboplatin is FDA approved and commercially available for the treatment of IBC.
FEC is FDA approved for breast cancer in general, but not specifically for inflammatory breast cancer.
The use of PNC and FEC together before surgery is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Panitumumab, Nab-paclitaxel, Carboplatin, 5-Fluorouracil, Epirubicin
- Keywords
- Inflammatory Breast Cancer, IBC, Primary breast carcinoma, HER2 negative overexpression, Panitumumab, Vectibix, Nab-paclitaxel, Paclitaxel, Abraxane, Carboplatin, Paraplatin, PNC, 5-fluorouracil, 5-FU, Adrucil, Efudex, Epirubicin, Ellence, Cyclophosphamide, Cytoxan
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanitumumabDrug
Also called Vectibix
2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12.
Nab-paclitaxelDrug
Also called Paclitaxel (protein-bound), Abraxane, ABI-007
100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes.
CarboplatinDrug
Also called Paraplatin
AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line.
5-FluorouracilDrug
Also called 5-FU, Adrucil, Efudex
500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
EpirubicinDrug
Also called Ellence
100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
CyclophosphamideDrug
Also called Cytoxan, Neosar
500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| PNC + FEC | Experimental | PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and
FEC = 5-fluorouracil, epirubicin, and cyclophosphamide Receives: Drug: Panitumumab; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Achieved Pathologic Complete Response (CR)
Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
Measured: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
Secondary outcomes (1)
Number of Participants With Treatment-related Adverse Events (AEs)
AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (>/=2 non-hematological and >/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section.
Measured: Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startNov 2010
- Primary completion11 Feb 2016
- Study completion9 Aug 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Amgen
- Responsible party
- Sponsor
- Investigators
- Naoto Ueno, MD, PHD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036087
- Sponsor's protocol ID
- 2008-0372
- Other IDs
- NCI-2012-00935
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2009
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Matsuda N, Wang X, Lim B, Krishnamurthy S, Alvarez RH, Willey JS, Parker CA, Song J, Shen Y, Hu J, Wu W, Li N, Babiera GV, Murray JL, Arun BK, Brewster AM, Reuben JM, Stauder MC, Barnett CM, Woodward WA, Le-Petross HTC, Lucci A, DeSnyder SM, Tripathy D, Valero V, Ueno NT. Safety and Efficacy of Panitumumab Plus Neoadjuvant Chemotherapy in Patients With Primary HER2-Negative Inflammatory Breast Cancer. JAMA Oncol. 2018 Sep 1;4(9):1207-1213. doi: 10.1001/jamaoncol.2018.1436.
PubMed 29879283
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression
- ClinicalTrials.gov ID
- NCT01036087
- Acronym / sponsor ID
- 2008-0372
- Conditions
- Breast Cancer
- Keywords
- Inflammatory Breast Cancer, IBC, Primary breast carcinoma, HER2 negative overexpression, Panitumumab, Vectibix, Nab-paclitaxel, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation, Amgen
- Study start
- Nov 2010 (actual)
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 21 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
Detailed description
Study Drugs:
Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR).
Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor.
Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow.
5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Study Drug Administration:
On Day 1 of Week 1, you will receive panitumumab through a needle in your vein over 60 minutes.
After Week 1, you will receive a total of 4 cycles of PNC. Each cycle is 4 weeks.
During Cycles 1-3 (Weeks 2-13), you will receive PNC by vein once a week for 3 weeks, followed by a week of rest. You will receive PNC through a needle in your vein. The infusion will take 90 minutes.
During Cycle 4 (Week 14 to 17), you will receive PNC on Day 1 of Weeks 14 and 15. On Day 1 of Week 16, you will receive only carboplatin and nab-paclitaxel.
Starting on Day 1 of Week 18, you will receive FEC through a needle in your vein. The infusion will take 90 minutes. You will receive a total of 4 cycles, each 3 weeks long, over 12 weeks.
Surgery:
After you have completed both PNC and FEC treatments, you will have the standard of care surgery performed. You will be given a separate consent form to read and sign.
During surgery, breast tissue samples will be collected to identify tumors as routine procedure.
Study Visits:
Each week that you receive PNC or FEC therapy, before each dose of chemotherapy, blood (about 1 1/2 tablespoons) will be drawn for routine tests.
Before Week 2, an optional breast core biopsy will be performed to collect tumor samples for biomarker testing
On Week 2, every 4 weeks after that until the end of PNC, and again before FEC, the following tests and procedures will be performed before each dose of chemotherapy.
- You will have a physical exam, including measurement of your vital signs and weight, and breast exam.
- Blood (about 1 1/2 tablespoons) will be drawn for routine tests.
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
During Weeks 2 and 9, and before FEC therapy, the study doctor will take pictures of both of your breasts.
Before FEC (after Cycle 4 of PNC) and again before surgery, the following tests and procedures will be performed:
- To check the status of the disease, imaging studies including mammogram, breast MRI, breast ultrasound, and digital photograph will be performed.
- You will have a physical exam, including vital signs, weight, and breast exam
- Blood (about 3 tablespoons) will be drawn for routine tests.
- You will be asked about any symptoms that you may have.
- The ECGs and ECHO/MUGA scans will be repeated, when the doctor thinks it is necessary.
This schedule may be changed if the study doctor thinks that it is necessary.
Length of the study:
You may remain on study treatment for up to 10 months. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. It's use in this study is considered to be investigational.
Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The use of Nab-paclitaxel in this study is considered to be investigational.
Carboplatin is FDA approved and commercially available for the treatment of IBC.
FEC is FDA approved for breast cancer in general, but not specifically for inflammatory breast cancer.
The use of PNC and FEC together before surgery is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNC + FEC | Experimental | Drug: Panitumumab, Drug: Nab-paclitaxel, Drug: Carboplatin, Drug: 5-Fluorouracil, Drug: Epirubicin, Drug: CyclophosphamidePNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological confirmation of breast carcinoma. Pathologic evidence of dermal lymphatic invasion should be noted but not required.
- Clinical diagnosis of IBC (presence of inflammatory changes in the involved breast, including diffuse erythema, heat, ridging, and peau d'orange).
- >/= Age 18
- ECOG performance status </= 1
- Adequate hematologic function: Absolute neutrophil count (ANC) >/= 1.5 x 109/L, Platelet count >/= 100 x 109/L, Hemoglobin >/= 9.0 g/dL
Key exclusion criteria (9 listed)
- History of radiation or chemotherapy
- HER2-positive breast carcinoma (IHC staining more than 3+ or HER2 gene amplification by FISH)
- Recurrent breast cancer
- History of other malignancies (except for cured non-melanomatous skin cancer or cured cervical carcinoma in situ, or malignancies with no evidence of disease and no treatment for >5 years)
- Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
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 |
|---|---|---|
| PanitumumabAlso: Vectibix2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12. | Drug | PNC + FEC |
| Nab-paclitaxelAlso: Paclitaxel (protein-bound), Abraxane, ABI-007100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes. | Drug | PNC + FEC |
| CarboplatinAlso: ParaplatinAUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line. | Drug | PNC + FEC |
| 5-FluorouracilAlso: 5-FU, Adrucil, Efudex500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). | Drug | PNC + FEC |
| EpirubicinAlso: Ellence100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). | Drug | PNC + FEC |
| CyclophosphamideAlso: Cytoxan, Neosar500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). | Drug | PNC + FEC |
Primary outcome
Number of Participants That Achieved Pathologic Complete Response (CR)
Time frame: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).
Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field.
1 secondary outcome
Number of Participants With Treatment-related Adverse Events (AEs)
Time frame: Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29879283Matsuda N, Wang X, Lim B, Krishnamurthy S, Alvarez RH, Willey JS, Parker CA, Song J, Shen Y, Hu J, Wu W, Li N, Babiera GV, Murray JL, Arun BK, Brewster AM, Reuben JM, Stauder MC, Barnett CM, Woodward WA, Le-Petross HTC, Lucci A, DeSnyder SM, Tripathy D, Valero V, Ueno NT. Safety and Efficacy of Panitumumab Plus Neoadjuvant Chemotherapy in Patients With Primary HER2-Negative Inflammatory Breast Cancer. JAMA Oncol. 2018 Sep 1;4(9):1207-1213. doi: 10.1001/jamaoncol.2018.1436.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Naoto Ueno, MD, PHD study chair
M.D. Anderson Cancer 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 Panitumumab, Nab-paclitaxel and Carboplatin in people with Breast Cancer, run by M.D. Anderson Cancer 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 21 Sep 2022). 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?
Number of Participants That Achieved Pathologic Complete Response (CR) (time frame: Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036087, which also lists 1 linked publication.
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 30 Mar 2023.