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Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial

This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere
(TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed
to assess (1) the clinical and pathologic response rates to this regimen, as well as its
tolerability in this subject population, and (2) the expression of Tiam1 in tumor-associated
fibroblasts pre and post treatment.

Inclusion Criteria:

- Women 18 years of age or older

- Histologically documented adenocarcinoma of the breast, with T2 (T>2.0 cm) N0 or more
advanced disease.

- No evidence of metastatic disease.

- Disease must be clinically or radio-graphically measurable or evaluable.

- Incisional or core needle biopsy, yielding sufficient tissue for histologic
confirmation of adenocarcinoma, hormone receptor analysis and Her2 testing; and
Tiam-1 expression.

- Subjects may have received no prior chemotherapy for breast cancer. Subjects may have
received up to 3 months of neoadjuvant hormonal therapy, provided they have been
re-staged and are still eligible for this study, and have been off hormonal therapy
at least 48 hours.

- Subject must be Her-2 negative.

- Performance status 0-1 by the ECOG scale.

- Baseline laboratory values must be as follows: Absolute granulocyte count: greater
than 1400/cells/ml; Platelets: greater than 100,000 cells/ml; Total bilirubin: less
than 1.5 mg/dl; Serum ALT: less than 2.5 x institutional upper normal limit;
Creatinine: less than 1.6mg/dl; Hemoglobin: greater than 9.0g/dl

- Subjects must be nonpregnant and nonlactating. Subjects of childbearing potential
must utilize an effective method of contraception during the study.

Exclusion Criteria:

- Subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone
therapy for this cancer.

- Subjects with metastatic disease (disease beyond the breast, axillary nodes and
ipsilateral supraclavicular nodes) or inflammatory breast cancer (T4d).

- Subjects with other active cancers, except non-melanoma skin cancers

- Subjects with an active serious infection or other serious underlying medical
condition that would otherwise impair their ability to receive protocol treatment.

- Dementia or significantly altered mental status that would prohibit comprehension of
or giving of informed consent.

- Pregnant or breast-feeding women; sexually active, pre-menopausal women not willing
to use adequate methods of birth control.

- Subjects who are Her 2 neu positive are excluded.

Type of Study:


Study Design:

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

Outcome Measure:

Complete Response Rate

Outcome Description:

The primary outcome measure for this study is the complete response rate for evaluable participants on neoadjuvant chemotherapy with cyclophosphamide and docetaxel. A clinical complete response (cCR) is defined as resolution of all palpable masses.

Outcome Time Frame:

3-4 weeks post-surgery

Safety Issue:


Principal Investigator

John S Nystrom, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tufts Medical Center


United States: Federal Government

Study ID:

Tufts BR01



Start Date:

October 2010

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms