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A Phase II Clinical Trial of Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy

35 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Clinical Trial of Drug Withdrawal in Women With Progressive Breast Cancer While on Aromatase Inhibitor Therapy

- Participants will have the following tests and procedures done at 8 weeks, 16 weeks,
and 24 weeks after stopping AI therapy: Physical examination; blood tests; tumor
assessment by physical exam (if possible); chest x-ray or CT scan of chest; CT scans of
abdomen and pelvis; and bone scan.

- After week 24, these procedures will be repeated every 12 weeks while the participant
is on the study.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the breast with
radiographically documented progressive or recurrent local-regional or metastatic
disease. Disease must not be considered amenable to curative treatment

- Evidence of hormone sensitivity (ER +ve and/or PR +ve) of primary or secondary tumor

- Measurable or nonmeasurable (but evaluable-defined as nontarget lesions) disease
according to modified RECIST. Patients with bone disease are eligible. These
patients will be evaluable only for the presence of stable or progressive disease and
not a PR or CR. Patients wih bone-only metastatic disease will be considered to have
stable disease if there is no evidence of new lesions and no clear progression of
existing lesions

- Postmenopausal, defined as fulfilling any of the following criteria: If > 50 year,
no menses within past 12 months, OR if < 50 years, no menses within past 12 months
AND FSH within post menopausal range OR bilateral oophorectomy

- Current AI monotherapy at the time of documented disease progression

- AI therapy must be discontinued at time of study entry or no longer than two weeks
prior to study entry

- Subjects receiving AI therapy for metastatic disease at the time of progression, must
have had a prior radiographic documented response to AI therapy or have been on
therapy for at least 6 months

- Subjects receiving AI as adjuvant therapy at the time of recurrence, must have been
treated with AI therapy for at least 12 months

- Prior antiestrogen therapies including tamoxifen, steroidal AIs, nonsteroidal AIs, or
faslodex in either the adjuvant or metastatic settings are allowed provided the
patient is currently on AI monotherapy (or within two weeks of discontinuation) and
has demonstrated a response or stable disease on the current AI

- Female

- Greater than 35 years of age

- ECOG performance status of 0, 1, or 2

Exclusion Criteria:

- Premenopausal

- Presence of life threatening metastatic disease, defined as extensive hepatic
involvement, any part or present brain or leptomeningeal involvement, or symptomatic
pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal
metastases will not be excluded, as long as their respiratory function is not
compromised as a result of pulmonary metastatic disease

- Patients who are highly symptomatic from their breast cancer, or who require urgent
palliative chemotherapy, as decided by their treating physician

- Prior or planned radiation therapy to single site of evaluable disease in the event
that the site is the only site of evaluable disease

- AST or ALT greater than 5 times the upper limit of normal in teh presence of
documented liver metastases

- Any severe concomitant condition believed to render subject undesirable for

- Systemic anticancer therapy including trastuzumab, chemotherapy, or other biologic
agents after discontinuation of AI therapy

- Hormone replacement therapy including topical or vaginal estrogen therapy within 3
months prior to discontinuation of AI therapy

- Chronic bisphosphonates for hypercalcemia or for prevention of bone metastases;
bisphosphonate therapy at the time of enrollment for documented bone metastases must
be continued

- Previous or current systemic malignancy within the past five years except for
contralateral breast carcinoma, in situ carcinoma of the cervix treated by cone
biopsy, or adequately treated basal or squamous cell carcinoma of the skin. Solid
tumors treated greater than 5 years ago and presumed cured are eligible

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To estimate the clinical benefit rate (CBR) after withdrawal of AI therapy in women with progressive or recurrent breast cancer while on AI therapy.

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Paul Goss, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2006

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • aromatase inhibitor
  • Breast Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617