Infiltrating Duct and Lobular Carcinoma In SituPhase 2NACprotocolNCT01641406
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
A Phase 2 study testing Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab in people with Infiltrating Duct and Lobular Carcinoma In Situ and Invasive Lobular Breast Carcinoma, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
Trial summary
The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infiltrating Duct and Lobular Carcinoma In Situ, Invasive Lobular Breast Carcinoma, Inflammatory Breast Carcinoma
- What is being tested?
- Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Mar 2011to Mar 2013
- 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
- Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer.
- Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible.
- Age≥ 18 years
- Only female patients are eligible
- Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is <1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by RECIST criteria, we will nevertheless include tumors≥1cm since the primary endpoint is pathological CR rate.
- Performance status ECOG≤2 or Karnofsky≥ 50%
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- Peripheral neuropathy≤ grade 1
- Hematologic (minimal values):Absolute Neutrophil count≥1,500/mm³; Hemoglobin≥8.0g/dl; Paltelet count≥100,000/mm³
- Hepatic; Total bilirubin≤ULN AST and ALT and ALP do not have to be within the range. In determining eligibility the more abnormal of the two values(AST or ALT) should be use as per protocol table on p.24of 69.
- Women of childbearing potential must have a negative pregnancy test
- Men and women of childbearing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months thereafter.
- Renal;urine protein:creatinine(UPC)ratio1.0 at screening or urine dipstick for proteinuria<2+(patients discovered to have˃/=2+ protinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate</=1g of protein in 24 hrs to be elegible
Who cannot join
- Pregnant or breast feeding patients are excluded
- Patients with second malignancies with expected survival<5 years
- Previous chemotherapy with Taxanes,Anthracyclines or Cyclophosphamide.
- Patientes with history of severe hypersensitivity reaction to Taxotere(Docetaxel)or other drugs formulated with polysorbate 80.
- Pure DCIS diagnoses are not elegible
- Special histologies with favorable prognosis such as mucinous, tubular are not elegible
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- Patients with reduced ejection fraction<50% are not eligible
- Patients with tumors<1.0cm unless biopsy proven axillary node metastasis present.
- Cardiac thrombotic events in the past 12 months
- Stroke or transient ischemic attacks (TIA) within 12 months
- poorly controlled hypertension defined as persistent blood pressure elevation˃150 systolic and/or 100 diastolic not responsive to medications.
- GI condition that increases risk of perforation within 6 months of study
- Any serious non-healing wound, ulcer, or bone fracture.
- No minor surgical procedure within 7 days of study entry or major surgery within 28 days of study entry or anticipation of need for major surgical procedure during the course of the study.
- Significant vascular disease such as symptomatic peripheral vascular disease.
- Any evidence of bleeding diathesis or coagulopathy.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site, 1 recruiting
- Recruiting
Hospital Auxilio Mutuo Cancer Center
San Juan, PR, 00918
Fernando Cabanillas, MD, 787-758-2000 ext. 3513, fcabanil@mdanderson.org
Idalia Liboy, MD, 787-758-2000 ext. 3569, iliboy@auxiliomutuo.com
About this study
The purpose of this study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.
Read the detailed description
Treatment propose of TEC-NAX for the triple negatives and for the Her2+ cases. For the Er+/Her2- cases, we propose to use the PET scan to guide therapy after the first course of TEC. Those who drop in SUV≤5%, will have their treatment modified by using the Oncotype test. Those Her2 negative patients whose response to the first 4 courses of induction TEC is less than a complete remission, will have their tretment changed to a second line regimen, Navelbine-Avastin-Xeloda(NAX), with the intention of capturing a better response prior to surgery. Those who are Her2+ will initially also receive TEC but subsequent therapy will include Trastuzumab(Herceptin) whether thet respond wellor not to TEC.
- Conditions
- Infiltrating Duct and Lobular Carcinoma In Situ, Invasive Lobular Breast Carcinoma, Inflammatory Breast Carcinoma
- Being tested
- Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
- Keywords
- NAC Protocol, NAC and Oncotype Guided Hormonal therapy for breast cancer, Neoadjuvant and Oncotype, NAC CCAM 1101
- Medical subject headings
- Breast Carcinoma In Situ, Carcinoma, Lobular, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabDrug
Also called Neoadjuvant chemotherapy for breast cancer
ER-(Triple Negative and ER-PR+Her-2-):Patients who respond to the first 4 courses of TEC with a Complete Remission will receive 4 more courses of TEC. Patients who respond to the first 4 courses of TEC with a Partial Remission or Stable Disease will then have their treatment changed to the non-cross resistant NAX regimen.Courses will be repeated every 21 days according to blood counts.A total of 4 courses will be given.
Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabDrug
Also called Neoadjuvant chemotherapy for breast cancer
Her-2 positive cases:Patients who respond to 4 courses of TEC with either a partial or complete remission will then receive 4 additional courses of Docetaxel plus Herceptin, and upon completion of the 4th course of DH they will undergo definitive surgery.A total of 4 courses will be given. Courses will be repeated every 21 days according to blood counts. Patients whose response after 4 courses of TEC is either stable disease or progression, will be treated with "NTX".
Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabDrug
Also called Neoadjuvant chemotherapy for breast cancer
ER+ Cases(ER+PR+Her-2- and ER+PR-Her-2-):After the first course of TEC if the SUV of the primary tumor is >5%, treatment will be TEC x 4 courses. If the Oncotype is low, patients will be switched to hormonal therapy x 6 months. If the Oncotype result is intermediate/high, patients will be NAX chemotherapy x 4 courses. If the SUV post course #1 TEC is <5%, subsequent treatment will depend on the Oncotype.If the Oncotype is low, the treatment will be hormonal therapy x 6 months. If the Oncotype is intermediate/high , the treatment will be NAX chemotherapy x 4. Surgery will be performed 6 weeks after the 4th course of NAX chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| ER- (Triple Neg. and ER- PR+ Her 2 -) | Experimental | Experimental chemotherapy using neoadjuvant approach Receives: Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab |
| Her 2 + | Experimental | Experimental chemotherapy using neoadjuvant approach Receives: Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab |
| ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -) | Experimental | Experimental chemotherapy using neoadjuvant approach Receives: Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to obtain a RCB rate of 0-1 in at least 66%
The primary objective is to raise the RCB rate of 0-1 to ≥40%. the startegy of using Oncotype test to guide NAC therapy will be considered encouraging for future testing if we are able to achieve this goal.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startMar 2011
- Primary completionJan 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infiltrating Duct and Lobular Carcinoma In SituStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auxilio Mutuo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Cabanillas, Auxilio Mutuo Cancer Center
- Investigators
- Fernando Cabanillas, MD, Principal investigator, Auxilio Mutuo Hospital Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641406
- Sponsor's protocol ID
- NAC CCAM 11-01
- Acronym
- NACprotocol
- Status last verified
- Jul 2012
- First submitted
- 11 Jul 2012
- Last updated
- 16 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"
- ClinicalTrials.gov ID
- NCT01641406
- Acronym / sponsor ID
- NACprotocol / NAC CCAM 11-01
- Conditions
- Infiltrating Duct and Lobular Carcinoma In Situ, Invasive Lobular Breast Carcinoma, Inflammatory Breast Carcinoma
- Keywords
- NAC Protocol, NAC and Oncotype Guided Hormonal therapy for breast cancer, Neoadjuvant and Oncotype, NAC CCAM 1101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Auxilio Mutuo Cancer CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 16 Jul 2012 (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 study is to evaluate a novel neoadjuvant regimen for invasive breast carcinoma by using the MD Anderson residual cancer burden score.To prospectively evaluate the utility of the PET scan to guide the neoadjuvant treatment and the utility of the Oncotype test as a stratifier for treatment decisons in ER+/Her2- patients. To evaluate the clinical anti-tumor activity of neoadjuvant hormonal therapy in ER+/Her2 negative patients. To evaluate the prognostic factors associated associated with pathological response as measured by the residual cancer burden tool.
Detailed description
Treatment propose of TEC-NAX for the triple negatives and for the Her2+ cases. For the Er+/Her2- cases, we propose to use the PET scan to guide therapy after the first course of TEC. Those who drop in SUV≤5%, will have their treatment modified by using the Oncotype test. Those Her2 negative patients whose response to the first 4 courses of induction TEC is less than a complete remission, will have their tretment changed to a second line regimen, Navelbine-Avastin-Xeloda(NAX), with the intention of capturing a better response prior to surgery. Those who are Her2+ will initially also receive TEC but subsequent therapy will include Trastuzumab(Herceptin) whether thet respond wellor not to TEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ER- (Triple Neg. and ER- PR+ Her 2 -) | Experimental | Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabExperimental chemotherapy using neoadjuvant approach |
| Her 2 + | Experimental | Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabExperimental chemotherapy using neoadjuvant approach |
| ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -) | Experimental | Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabExperimental chemotherapy using neoadjuvant approach |
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)
- Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast cancer.
- Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinoma will also be elegible.
- Age≥ 18 years
- Only female patients are eligible
- Tumor≥ 1.0cm by MRI and/or sonographic or clinical exam measurements. If the tumor is <1.0 but the patient has biopsy proven lymph node metastasis, she will also be considered eligible.Although only tumors≥2cm are consideredmeasurable by RECIST criteria, we will nevertheless include tumors≥1cm since the primary endpoint is pathological CR rate.
Key exclusion criteria (16 listed)
- Pregnant or breast feeding patients are excluded
- Patients with second malignancies with expected survival<5 years
- Previous chemotherapy with Taxanes,Anthracyclines or Cyclophosphamide.
- Patientes with history of severe hypersensitivity reaction to Taxotere(Docetaxel)or other drugs formulated with polysorbate 80.
- Pure DCIS diagnoses are not elegible
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, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabAlso: Neoadjuvant chemotherapy for breast cancerER-(Triple Negative and ER-PR+Her-2-):Patients who respond to the first 4 courses of TEC with a Complete Remission will receive 4 more courses of TEC. Patients who respond to the first 4 courses of TEC with a Partial Remission or Stable Disease will then have their treatment changed to the non-cross resistant NAX regimen.Courses will be repeated every 21 days according to blood counts.A total of 4 courses will be given. | Drug | ER- (Triple Neg. and ER- PR+ Her 2 -) |
| Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabAlso: Neoadjuvant chemotherapy for breast cancerHer-2 positive cases:Patients who respond to 4 courses of TEC with either a partial or complete remission will then receive 4 additional courses of Docetaxel plus Herceptin, and upon completion of the 4th course of DH they will undergo definitive surgery.A total of 4 courses will be given. Courses will be repeated every 21 days according to blood counts. Patients whose response after 4 courses of TEC is either stable disease or progression, will be treated with "NTX". | Drug | Her 2 + |
| Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, BevacizumabAlso: Neoadjuvant chemotherapy for breast cancerER+ Cases(ER+PR+Her-2- and ER+PR-Her-2-):After the first course of TEC if the SUV of the primary tumor is >5%, treatment will be TEC x 4 courses. If the Oncotype is low, patients will be switched to hormonal therapy x 6 months. If the Oncotype result is intermediate/high, patients will be NAX chemotherapy x 4 courses. If the SUV post course #1 TEC is <5%, subsequent treatment will depend on the Oncotype.If the Oncotype is low, the treatment will be hormonal therapy x 6 months. If the Oncotype is intermediate/high , the treatment will be NAX chemotherapy x 4. Surgery will be performed 6 weeks after the 4th course of NAX chemotherapy. | Drug | ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -) |
Primary outcome
The primary objective is to obtain a RCB rate of 0-1 in at least 66%
Time frame: 2 years
The primary objective is to raise the RCB rate of 0-1 to ≥40%. the startegy of using Oncotype test to guide NAC therapy will be considered encouraging for future testing if we are able to achieve this goal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
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.
Fernando Cabanillas, MD principal investigator
Auxilio Mutuo Hospital 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 Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab in people with Infiltrating Duct and Lobular Carcinoma In Situ and Invasive Lobular Breast Carcinoma, run by Auxilio Mutuo Cancer Center at 1 site in Puerto Rico.
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 16 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 16 Jul 2012. 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 Puerto Rico. 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?
Contact Fernando Cabanillas, MD (787-758-2000 ext. 3513, fcabanil@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to obtain a RCB rate of 0-1 in at least 66% (time frame: 2 years). 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 16 Jul 2012.