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Phase 3
18 Years
50 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Inclusion Criteria:

1. Patients must be premenopausal women with a histologically confirmed diagnosis of
operable Stage I, II, or IIIA invasive breast cancer. Patients who have completed
surgery must have pathologic Stage I, II, or IIIa disease. Patients to be treated in
the preoperative setting may be staged clinically but must have operable disease. For
the purposes of this study, premenopausal is defined as the presence of cyclic
menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and
estradiol levels in the premenopausal range.

2. Patients must have tumors that are both estrogen receptor negative and progesterone
receptor negative.

3. Patients must be of age 18 or greater and under age 50.

4. The patient's planned treatment must include 3 to 8 months or cycles of an alkylating
agent containing post-operative or pre-operative chemotherapy regimen that can be
anthracycline-based or non-anthracycline-based.

5. For patients receiving chemotherapy in the pre-operative setting, there must be no
intention to give additional chemotherapy in the postoperative setting

6. Patients receiving post-operative chemotherapy must be registered within 84 days
after the final surgical procedure required to adequately treat the primary tumor or

7. Patients must not have received prior cytotoxic chemotherapy for this breast cancer
or for any condition. Patients currently enrolled on S0221 are eligible for this

8. Patients must not have received estrogens, antiestrogens, selective estrogen receptor
modulators, aromatase inhibitors, or hormonal forms of contraception within the past
month with the following exceptions: Women under the age of 35 may have had recent
use of oral contraceptive pills but these must be discontinued prior to
randomization. In addition, for women of all ages, up to two months of hormonal
treatments for oocyte collection for the purposes of in vitro fertilization and
cryopreservation of embryos or oocytes is permitted provided these treatments are
complete prior to randomization.

Women using oral contraceptive pills or hormonal treatments for oocyte collection
during the month prior to enrollment must have documentation of FSH and estradiol
levels in the premenopausal range.

9. No prior malignancy is allowed except for adequately treated basal cell (or squamous
cell) skin cancer, in situ cancer or other cancer for which the patient has been
diseasefree for five years after treatment with curative intent.

10. Patients must have a performance status of 0 - 2 by Zubrod criteria (see Section

11. Pregnant or nursing women may not participate due to the possibility of fetal harm or
of harm to nursing infants from this treatment regimen. Women of reproductive
potential must agree to use an effective barrier contraceptive method.

13. All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The study is to compare the rate of premature ovarian failure at two years following standard adjuvant or neoadjuvant chemotherapy

Outcome Time Frame:

Three years

Safety Issue:


Principal Investigator

Adher Al Sayed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Faisal Specialist Hospital & Research Center


United States: Federal Government

Study ID:




Start Date:

November 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Early Stage Breast Cancer
  • Reduce Ovarian Failure Following Chemotherapy
  • Breast Neoplasms
  • Menopause, Premature
  • Primary Ovarian Insufficiency