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"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

Phase 2
18 Years
Open (Enrolling)
Infiltrating Duct and Lobular Carcinoma In Situ, Invasive Lobular Breast Carcinoma, Inflammatory Breast Carcinoma

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Trial Information

"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer"

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.

Inclusion Criteria:

- Previously untreated (no chemotherapy, hormonal or radiation therapy)invasive breast

- 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 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to obtain a RCB rate of 0-1 in at least 66%

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Fernando Cabanillas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Auxilio Mutuo Hospital Cancer Center


United States: Food and Drug Administration

Study ID:

NAC CCAM 11-01



Start Date:

March 2011

Completion Date:

March 2013

Related Keywords:

  • Infiltrating Duct and Lobular Carcinoma In Situ
  • Invasive Lobular Breast Carcinoma
  • Inflammatory Breast Carcinoma
  • NAC Protocol
  • NAC and Oncotype Guided Hormonal therapy for breast cancer
  • Neoadjuvant and Oncotype
  • NAC CCAM 1101
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Lobular
  • Inflammatory Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating