"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" (NACprotocol)
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ClinicalTrials.gov Identifier: NCT01641406 |
Recruitment Status
: Unknown
Verified July 2012 by Fernando Cabanillas, Auxilio Mutuo Cancer Center.
Recruitment status was: Recruiting
First Posted
: July 16, 2012
Last Update Posted
: July 16, 2012
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Condition or disease | Intervention/treatment | Phase |
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Infiltrating Duct and Lobular Carcinoma In Situ Invasive Lobular Breast Carcinoma Inflammatory Breast Carcinoma | Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | "Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" |
Study Start Date : | March 2011 |
Estimated Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
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Experimental: ER- (Triple Neg. and ER- PR+ Her 2 -)
Experimental chemotherapy using neoadjuvant approach
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Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
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.
Other Name: Neoadjuvant chemotherapy for breast cancer
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Experimental: Her 2 +
Experimental chemotherapy using neoadjuvant approach
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Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
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".
Other Name: Neoadjuvant chemotherapy for breast cancer
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Experimental: ER + (ER+ PR+ Her 2- / ER+ PR- Her 2 -)
Experimental chemotherapy using neoadjuvant approach
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Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
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.
Other Name: Neoadjuvant chemotherapy for breast cancer
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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%
- 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
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641406
Contact: Fernando Cabanillas, MD | 787-758-2000 ext 3513 | fcabanil@mdanderson.org | |
Contact: Idalia Liboy, MD | 787-758-2000 ext 3569 | iliboy@auxiliomutuo.com |
Puerto Rico | |
Hospital Auxilio Mutuo Cancer Center | Recruiting |
San Juan, Puerto Rico, 00918 | |
Contact: Fernando Cabanillas, MD 787-758-2000 ext 3513 fcabanil@mdanderson.org | |
Contact: Idalia Liboy, MD 787-758-2000 ext 3569 iliboy@auxiliomutuo.com | |
Principal Investigator: Fernando Cabanillas, MD |
Principal Investigator: | Fernando Cabanillas, MD | Auxilio Mutuo Hospital Cancer Center |
Responsible Party: | Fernando Cabanillas, Hematolgist-Oncologist, Auxilio Mutuo Cancer Center |
ClinicalTrials.gov Identifier: | NCT01641406 History of Changes |
Obsolete Identifiers: | NCT01330212 |
Other Study ID Numbers: |
NAC CCAM 11-01 |
First Posted: | July 16, 2012 Key Record Dates |
Last Update Posted: | July 16, 2012 |
Last Verified: | July 2012 |
Keywords provided by Fernando Cabanillas, Auxilio Mutuo Cancer Center:
NAC Protocol NAC and Oncotype Guided Hormonal therapy for breast cancer Neoadjuvant and Oncotype NAC CCAM 1101 |
Additional relevant MeSH terms:
Carcinoma Breast Neoplasms Carcinoma in Situ Carcinoma, Lobular Breast Carcinoma In Situ Inflammatory Breast Neoplasms Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Adenocarcinoma |
Neoplasms, Ductal, Lobular, and Medullary Carcinoma, Ductal Bevacizumab Docetaxel Vinorelbine Cyclophosphamide Capecitabine Trastuzumab Epirubicin Vinblastine Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |